Trial Outcomes & Findings for Neonatal Sleep Intervention to Improve Postpartum Hypertension (NCT NCT04864249)
NCT ID: NCT04864249
Last Updated: 2023-06-08
Results Overview
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
6 weeks postpartum
Results posted on
2023-06-08
Participant Flow
Participant milestones
| Measure |
SNOO Responsive Bassinet
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
COMPLETED
|
45
|
31
|
|
Overall Study
NOT COMPLETED
|
9
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participant data not available in chart review
Baseline characteristics by cohort
| Measure |
SNOO Responsive Bassinet
n=54 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=56 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 5.5 • n=54 Participants
|
30.5 years
STANDARD_DEVIATION 4.8 • n=56 Participants
|
31.1 years
STANDARD_DEVIATION 5.2 • n=110 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=54 Participants
|
56 Participants
n=56 Participants
|
110 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
2 Participants
n=56 Participants
|
3 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=54 Participants
|
54 Participants
n=56 Participants
|
107 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=110 Participants
|
|
Race/Ethnicity, Customized
Self-reported race · Black
|
10 Participants
n=54 Participants
|
10 Participants
n=56 Participants
|
20 Participants
n=110 Participants
|
|
Race/Ethnicity, Customized
Self-reported race · White
|
43 Participants
n=54 Participants
|
41 Participants
n=56 Participants
|
84 Participants
n=110 Participants
|
|
Race/Ethnicity, Customized
Self-reported race · Asian or Pacific Islander
|
1 Participants
n=54 Participants
|
2 Participants
n=56 Participants
|
3 Participants
n=110 Participants
|
|
Race/Ethnicity, Customized
Self-reported race · Other
|
0 Participants
n=54 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=110 Participants
|
|
Partner status
Married or partnered
|
49 Participants
n=54 Participants
|
43 Participants
n=56 Participants
|
92 Participants
n=110 Participants
|
|
Partner status
Separated or divorced
|
0 Participants
n=54 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=110 Participants
|
|
Partner status
Single
|
5 Participants
n=54 Participants
|
11 Participants
n=56 Participants
|
16 Participants
n=110 Participants
|
|
Annual household income
<$75,000
|
21 Participants
n=54 Participants
|
26 Participants
n=56 Participants
|
47 Participants
n=110 Participants
|
|
Annual household income
$75,000+
|
31 Participants
n=54 Participants
|
24 Participants
n=56 Participants
|
55 Participants
n=110 Participants
|
|
Annual household income
Prefer not to answer
|
2 Participants
n=54 Participants
|
6 Participants
n=56 Participants
|
8 Participants
n=110 Participants
|
|
Insurance status during pregnancy
Private
|
42 Participants
n=54 Participants
|
36 Participants
n=56 Participants
|
78 Participants
n=110 Participants
|
|
Insurance status during pregnancy
Public
|
9 Participants
n=54 Participants
|
17 Participants
n=56 Participants
|
26 Participants
n=110 Participants
|
|
Insurance status during pregnancy
Other
|
1 Participants
n=54 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=110 Participants
|
|
Insurance status during pregnancy
No insurance
|
2 Participants
n=54 Participants
|
2 Participants
n=56 Participants
|
4 Participants
n=110 Participants
|
|
Other children also living at home
|
25 Participants
n=54 Participants
|
23 Participants
n=56 Participants
|
48 Participants
n=110 Participants
|
|
Smoking within the past 2 years
|
6 Participants
n=54 Participants
|
8 Participants
n=56 Participants
|
14 Participants
n=110 Participants
|
|
Pre-delivery diagnosis of depression
|
17 Participants
n=54 Participants
|
18 Participants
n=56 Participants
|
35 Participants
n=110 Participants
|
|
Ever breastfeed
|
48 Participants
n=54 Participants
|
49 Participants
n=56 Participants
|
97 Participants
n=110 Participants
|
|
Gestational age at delivery
|
38.1 weeks
n=54 Participants
|
38.1 weeks
n=56 Participants
|
38.1 weeks
n=110 Participants
|
|
Mode of delivery
Vaginal delivery
|
35 Participants
n=54 Participants
|
31 Participants
n=56 Participants
|
66 Participants
n=110 Participants
|
|
Mode of delivery
Forceps-assisted vaginal delivery
|
1 Participants
n=54 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=110 Participants
|
|
Mode of delivery
Vacuum-assisted vaginal delivery
|
0 Participants
n=54 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=110 Participants
|
|
Mode of delivery
Cesarean delivery
|
18 Participants
n=54 Participants
|
21 Participants
n=56 Participants
|
39 Participants
n=110 Participants
|
|
Blood loss during delivery
|
300 mL
n=54 Participants
|
300 mL
n=56 Participants
|
300 mL
n=110 Participants
|
|
Neonatal birthweight
|
3155 g
n=54 Participants
|
3055 g
n=56 Participants
|
3125 g
n=110 Participants
|
|
Type of hypertensive disorder
Gestational hypertension
|
24 Participants
n=54 Participants
|
33 Participants
n=56 Participants
|
57 Participants
n=110 Participants
|
|
Type of hypertensive disorder
Preeclampsia without severe features
|
15 Participants
n=54 Participants
|
11 Participants
n=56 Participants
|
26 Participants
n=110 Participants
|
|
Type of hypertensive disorder
Preeclampsia with severe features
|
15 Participants
n=54 Participants
|
12 Participants
n=56 Participants
|
27 Participants
n=110 Participants
|
|
Gestational age at diagnosis of hypertensive disorder
|
38.0 weeks
n=54 Participants
|
37.9 weeks
n=56 Participants
|
37.9 weeks
n=110 Participants
|
|
Mean arterial pressure at first prenatal visit
|
87 mm Hg
STANDARD_DEVIATION 7 • n=54 Participants • Some participant data not available in chart review
|
90 mm Hg
STANDARD_DEVIATION 8 • n=54 Participants • Some participant data not available in chart review
|
89 mm Hg
STANDARD_DEVIATION 8 • n=108 Participants • Some participant data not available in chart review
|
|
Systolic blood pressure at first prenatal visit
|
115 mm Hg
STANDARD_DEVIATION 10 • n=54 Participants • Some participant data not available in chart review
|
119 mm Hg
STANDARD_DEVIATION 9 • n=54 Participants • Some participant data not available in chart review
|
118 mm Hg
STANDARD_DEVIATION 10 • n=108 Participants • Some participant data not available in chart review
|
|
Diastolic blood pressure at first prenatal visit
|
73 mm Hg
STANDARD_DEVIATION 8 • n=54 Participants • Some participant data not available in chart review
|
76 mm Hg
STANDARD_DEVIATION 9 • n=54 Participants • Some participant data not available in chart review
|
74 mm Hg
STANDARD_DEVIATION 9 • n=108 Participants • Some participant data not available in chart review
|
|
Weight in kg at first prenatal visit
|
74.8 kg
n=54 Participants • Some participant data not available in chart review
|
81.0 kg
n=54 Participants • Some participant data not available in chart review
|
76.3 kg
n=108 Participants • Some participant data not available in chart review
|
|
Body Mass Index in kg/m^2 at first prenatal visit
|
27.7 kg/m^2
n=54 Participants • Some participant data not available in chart review
|
30.0 kg/m^2
n=54 Participants • Some participant data not available in chart review
|
29.1 kg/m^2
n=108 Participants • Some participant data not available in chart review
|
|
Mean arterial pressure on Labor and Delivery admission
|
103 mm Hg
STANDARD_DEVIATION 12 • n=54 Participants
|
102 mm Hg
STANDARD_DEVIATION 9 • n=56 Participants
|
103 mm Hg
STANDARD_DEVIATION 11 • n=110 Participants
|
|
Systolic blood pressure on Labor and Delivery admission
|
140 mm Hg
STANDARD_DEVIATION 13 • n=54 Participants
|
135 mm Hg
STANDARD_DEVIATION 12 • n=56 Participants
|
138 mm Hg
STANDARD_DEVIATION 13 • n=110 Participants
|
|
Diastolic blood pressure on Labor and Delivery admission
|
86 mm Hg
STANDARD_DEVIATION 13 • n=54 Participants
|
86 mm Hg
STANDARD_DEVIATION 10 • n=56 Participants
|
86 mm Hg
STANDARD_DEVIATION 12 • n=110 Participants
|
|
Weight on Labor and Delivery admission in kg
|
90.9 kg
n=54 Participants
|
93.5 kg
n=56 Participants
|
91.6 kg
n=110 Participants
|
|
Body Mass Index on Labor and Delivery admission in kg/m^2
|
33.8 kg/m^2
n=54 Participants
|
35.5 kg/m^2
n=56 Participants
|
34.9 kg/m^2
n=110 Participants
|
|
Mean arterial pressure at postpartum enrollment
|
102 mm Hg
STANDARD_DEVIATION 8 • n=54 Participants
|
102 mm Hg
STANDARD_DEVIATION 11 • n=56 Participants
|
102 mm Hg
STANDARD_DEVIATION 10 • n=110 Participants
|
|
Systolic blood pressure at postpartum enrollment
|
135 mm Hg
STANDARD_DEVIATION 12 • n=54 Participants
|
134 mm Hg
STANDARD_DEVIATION 14 • n=56 Participants
|
135 mm Hg
STANDARD_DEVIATION 13 • n=110 Participants
|
|
Diastolic blood pressure at postpartum enrollment
|
85 mm Hg
STANDARD_DEVIATION 8 • n=54 Participants
|
86 mm Hg
STANDARD_DEVIATION 10 • n=56 Participants
|
86 mm Hg
STANDARD_DEVIATION 9 • n=110 Participants
|
|
Number of participants on antihypertensive medication(s) at postpartum enrollment
|
4 Participants
n=54 Participants
|
3 Participants
n=56 Participants
|
7 Participants
n=110 Participants
|
|
Number of participants with Stage 1+ hypertension or on antihypertensive medication(s)
|
9 Participants
n=54 Participants
|
11 Participants
n=56 Participants
|
20 Participants
n=110 Participants
|
|
Weight at postpartum enrollment in kg
|
87.2 kg
n=54 Participants
|
92.7 kg
n=56 Participants
|
88.6 kg
n=110 Participants
|
|
Body Mass Index at postpartum enrollment in kg/m^2
|
32.2 kg/m^2
n=54 Participants
|
34.5 kg/m^2
n=56 Participants
|
33.2 kg/m^2
n=110 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Mean Arterial Pressure
|
93 mm Hg
Standard Deviation 8
|
94 mm Hg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Mean Arterial Pressure
|
99 mm Hg
Standard Deviation 10
|
103 mm Hg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Systolic Blood Pressure
|
131 mm Hg
Standard Deviation 14
|
130 mm Hg
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Diastolic Blood Pressure
|
83 mm Hg
Standard Deviation 11
|
89 mm Hg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Number of Participants on Antihypertensive Medication(s)
|
12 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
|
43 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Maternal Weight in Kilograms
|
81.2 kg
Interval 70.6 to 94.3
|
88.0 kg
Interval 69.8 to 104.1
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=49 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Body Mass Index in kg/m^2
|
29.4 kg/m^2
Interval 26.3 to 39.8
|
31.6 kg/m^2
Interval 28.0 to 37.9
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Systolic Blood Pressure
|
121 mm Hg
Standard Deviation 10
|
122 mm Hg
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Diastolic Blood Pressure
|
79 mm Hg
Standard Deviation 8
|
80 mm Hg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Number of Participants on Antihypertensive Medication(s)
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
|
31 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Maternal Weight in Kilograms
|
76.7 kg
Interval 69.0 to 93.6
|
87.0 kg
Interval 69.4 to 103.4
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=53 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=51 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Body Mass Index
|
28.5 kg/m^2
Interval 25.7 to 35.4
|
32.1 kg/m^2
Interval 26.2 to 37.6
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Mean Arterial Pressure
|
93 mm Hg
Standard Deviation 9
|
94 mm Hg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Systolic Blood Pressure
|
121 mm Hg
Standard Deviation 10
|
122 mm Hg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Diastolic Blood Pressure
|
78 mm Hg
Standard Deviation 10
|
80 mm Hg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Number of Participants on Antihypertensive Medication(s)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Maternal Weight in Kilograms
|
77.2 kg
Interval 67.1 to 87.1
|
85.8 kg
Interval 68.5 to 102.1
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=45 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=31 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Body Mass Index in kg/m^2
|
27.8 kg/m^2
Interval 25.0 to 34.7
|
31.6 kg/m^2
Interval 25.8 to 36.5
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The Pittsburgh Sleep Quality Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate if one is available; only the self-rated questions are included in the scoring. Scores range from 0 (indicating no difficulties in any aspect of sleep) to 21 (indicating severe difficulties in all areas).
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Pittsburgh Sleep Quality Index Score
|
8.5 score on a scale
Standard Deviation 3.0
|
8.9 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The PROMIS Sleep Disturbance Questionnaire contains 27 self-rated questions on subjective sleep quality. Scores range from 27 (indicating excellent sleep quality) to 135 (indicating poor sleep quality).
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
PROMIS Sleep Disturbance Questionnaire
|
55 units on a scale
Standard Deviation 17
|
58 units on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The Epworth Sleepiness Scale contains 8 self-rated questions to determine the level of daytime sleepiness in individuals. Scores range from 0 to 24. A score of 10 or more is concerning for excessive daytime sleepiness.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Epworth Sleepiness Scale Score
|
8.3 score on a scale
Standard Deviation 4.1
|
7.9 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The Edinburgh Postnatal Depression Scale contains 10 self-rated questions to assess for major depression in the postnatal period. Scores range from 0 to 30. A score of 13 or greater is concerning for major depression.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Edinburgh Postnatal Depression Scale Score
|
5 score on a scale
Interval 2.0 to 9.0
|
3 score on a scale
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The Generalized Anxiety Disorder 2-item contains 2 self-rated questions to screen for generalized anxiety disorder. Scores range from 0 to 6. A score of 3 or greater is concerning for generalized anxiety disorder.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Generalized Anxiety Disorder 2-item Score
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The Perceived Stress Scale 4 contains 4 self-rated questions regarding stress levels. Scores range from 0 to 16. Higher scores a correlated to more stress.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Perceived Stress Scale 4 Score
|
3.5 score on a scale
Interval 2.0 to 5.0
|
3.5 score on a scale
Interval 2.0 to 5.5
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
The Breslau 7-Item Screen for Posttraumatic Stress Disorder contains 7 self-rated questions assessing symptoms of post-traumatic stress disorder. Scores range from 0 to 7. Scores of 4 or above are concerning for post-traumatic stress disorder.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=48 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=34 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Breslau 7-Item Screen for Post-traumatic Stress Disorder Score
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=42 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=22 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Infant Total Daily Sleep
|
13.6 hours per day
Interval 12.1 to 14.9
|
13.7 hours per day
Interval 13.0 to 15.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=42 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=22 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Infant Daily Longest Sleep Duration
|
4.0 hours per day
Interval 3.5 to 4.6
|
4.0 hours per day
Interval 3.1 to 4.4
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=42 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=22 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Maternal Total Daily Sleep
|
6.4 hours per day
Interval 5.9 to 7.7
|
7.4 hours per day
Interval 6.9 to 7.9
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=42 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=22 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Maternal Daily Longest Sleep Duration
|
3.4 hours per day
Interval 2.8 to 4.1
|
3.6 hours per day
Interval 3.1 to 4.9
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=41 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=20 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Infant Total Daily Sleep
|
13.2 hours per day
Interval 11.9 to 13.9
|
13.5 hours per day
Interval 12.8 to 14.1
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=41 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=20 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Infant Daily Longest Sleep Duration
|
7.7 hours per day
Interval 5.6 to 8.9
|
6.5 hours per day
Interval 5.2 to 7.7
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=41 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=20 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Maternal Total Daily Sleep
|
7.3 hours per day
Interval 6.2 to 8.0
|
7.8 hours per day
Interval 6.9 to 8.2
|
SECONDARY outcome
Timeframe: 4 months postpartumPopulation: Some participants lost to follow-up and/or did not complete this outcome measure
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Outcome measures
| Measure |
SNOO Responsive Bassinet
n=41 Participants
Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Usual Care
n=20 Participants
Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
|---|---|---|
|
Median Maternal Daily Longest Sleep Duration
|
5.9 hours per day
Interval 4.3 to 7.1
|
5.1 hours per day
Interval 4.2 to 6.9
|
Adverse Events
SNOO Responsive Bassinet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alisse Hauspurg
University of Pittsburgh Medical Center, Magee-Womens Hospital
Phone: 412-641-1381
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place