Trial Outcomes & Findings for Neonatal Warming to Prevent Hypothermia (NCT NCT04827394)
NCT ID: NCT04827394
Last Updated: 2024-05-01
Results Overview
Temperature at arrival to the Warmer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
3 minutes
Results posted on
2024-05-01
Participant Flow
The values reported reflect the total number of unique participants (mothers) assigned to each Arm.
Participant milestones
| Measure |
Warming Mattress and Sterile Polyethylene Wrap Group
In the intervention group, the infant was placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Standard of Care Group
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Warming Mattress and Sterile Polyethylene Wrap Group
In the intervention group, the infant was placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Standard of Care Group
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Neonatal Warming to Prevent Hypothermia
Baseline characteristics by cohort
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Maternal Age
|
31.9 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Gestational age
|
241.0 days
STANDARD_DEVIATION 10.8 • n=5 Participants
|
242.1 days
STANDARD_DEVIATION 11.1 • n=7 Participants
|
241.6 days
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Number of prenatal visits
|
6.5 visits
STANDARD_DEVIATION 3.0 • n=5 Participants
|
6.6 visits
STANDARD_DEVIATION 3.3 • n=7 Participants
|
6.6 visits
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Body Mass Index (kg/m2)
|
34.2 kg/m2
n=5 Participants
|
32.5 kg/m2
n=7 Participants
|
33.35 kg/m2
n=5 Participants
|
|
Payor Status
Private
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Payor Status
Government/Self
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Recevied Prenatal Care
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Maternal Labor
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Rupture of Membranes
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Meconium Stain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Maternal Complications
Chronic Hypertension
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Maternal Complications
Gestational Hypertension
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Maternal Complications
Preeclampsia Without Severe Features
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Maternal Complications
Preeclampsia With Severe Features
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Maternal Complications
Eclampsia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Maternal Complications
HELLP
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Maternal Complications
Thyroid Disorder
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Maternal Complications
None
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
NICU Admission
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Fetal Complications
Twins
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Fetal Complications
Fetal Growth Restriction
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Fetal Complications
Oligohydramnios
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Fetal Complications
Polyhydramnios
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Fetal Complications
Sepsis
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Fetal Complications
Death
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 minutesTemperature at arrival to the Warmer
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Temperature at Arrival to Warmer
|
36.9 degrees Celsius
Interval 36.5 to 37.3
|
37.0 degrees Celsius
Interval 36.8 to 37.1
|
SECONDARY outcome
Timeframe: 3 minutesThe temperature at exit is only available for n=21 in treatment groups and n=19 in control group.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=19 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Temperature at Exit
|
36.8 degrees Celsius
Interval 36.4 to 37.0
|
36.7 degrees Celsius
Interval 36.6 to 37.0
|
SECONDARY outcome
Timeframe: 24 hoursTemperature at admission to NICU/Recovery
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Temperature at NICU/Recovery
|
36.6 degrees Celsius
Interval 36.4 to 36.8
|
36.5 degrees Celsius
Interval 36.3 to 36.8
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsHighest bilirubin level of infant based on blood test
Outcome measures
| Measure |
Intervention Group
n=23 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=21 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Peak Bilirubin
|
9.0 mg/dl
Interval 5.0 to 10.0
|
9.0 mg/dl
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsDuration of respiratory support in the form of intubation or continuous positive airway pressure (if applicable)
Outcome measures
| Measure |
Intervention Group
n=16 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=17 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Duration of Respiratory Support
|
114.3 hours
Interval 2.1 to 189.9
|
31.2 hours
Interval 14.8 to 169.5
|
SECONDARY outcome
Timeframe: Up to 60 seconds after birthLength of delayed cord clamp in seconds
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Length of Delayed Cord Clamp
|
61.0 seconds
Interval 60.0 to 66.0
|
62.0 seconds
Interval 33.0 to 65.0
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsLength of hospital stay in days
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Length of Hospital Stay
|
11.0 days
Interval 5.0 to 20.0
|
7.0 days
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsAge to wean to crib in days
Outcome measures
| Measure |
Intervention Group
n=24 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=23 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Age to Wean to Crib
|
3.0 days
Interval 0.0 to 8.0
|
1.0 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Immediately after cord clamping (up to 60 seconds after birth)Number of infants with hypothermia at time of arrival to warmer
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Hypothermia at Warmer
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsHypothermia at the Completion of Resuscitation
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Hypothermia at Completion of Resuscitation
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsHypothermia at NICU admission /Recovery
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Hypothermia at NICU/Recovery
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsHyperthermia (\>37.5C) at arrival to Warmer
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Hyperthermia (>37.5C) at Warmer
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 24 hoursHypoglycemia (less than 30mg/dL in the first 24 hours)
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Hypoglycemia
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 24 hoursWhether or not infant was admitted to NICU
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Need for NICU Admission
|
16 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Through hospital discharge up to 3 monthsComposite neonatal morbidity (if applicable)
Outcome measures
| Measure |
Intervention Group
n=25 Participants
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Control Group
n=25 Participants
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|
|
Composite
|
1 participants
|
1 participants
|
Adverse Events
Warming Mattress and Sterile Polyethylene Wrap Group-Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Group-Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Warming Mattress and Sterile Polyethylene Wrap Group-Infants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Standard of Care Group-Infants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Warming Mattress and Sterile Polyethylene Wrap Group-Mothers
n=25 participants at risk
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Standard of Care Group-Mothers
n=25 participants at risk
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
Warming Mattress and Sterile Polyethylene Wrap Group-Infants
n=25 participants at risk
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
|
Standard of Care Group-Infants
n=25 participants at risk
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Elevated temperature
|
0.00%
0/25 • Through discharge, assessed up to 3 months per participant
Adverse events were collected for participants throughout their participation in the study, up to their hospital or NICU discharge.
|
0.00%
0/25 • Through discharge, assessed up to 3 months per participant
Adverse events were collected for participants throughout their participation in the study, up to their hospital or NICU discharge.
|
8.0%
2/25 • Number of events 2 • Through discharge, assessed up to 3 months per participant
Adverse events were collected for participants throughout their participation in the study, up to their hospital or NICU discharge.
|
4.0%
1/25 • Number of events 1 • Through discharge, assessed up to 3 months per participant
Adverse events were collected for participants throughout their participation in the study, up to their hospital or NICU discharge.
|
Additional Information
Birju Shah, MD
University of Oklahoma Health Sciences Center
Phone: 405-271-5215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place