Trial Outcomes & Findings for A Clinical Trial of A Pacifier-Activated Music Player (NCT NCT01600586)
NCT ID: NCT01600586
Last Updated: 2018-05-07
Results Overview
Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention
COMPLETED
NA
100 participants
Day 0, and Day 5
2018-05-07
Participant Flow
PI has left Vanderbilt, data obtained from publication http://pediatrics.aappublications.org/content/133/3/462.full
Participant milestones
| Measure |
Books, PAL Group
PAL group
Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL).
|
Books, No PAL Group
No PAL
At enrollment, all mother-infant dyads received a set of 4 well-known children's books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study's objective was to evaluate the influence of their voice on their infant's feeding ability.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Books, PAL Group
PAL group
Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL).
|
Books, No PAL Group
No PAL
At enrollment, all mother-infant dyads received a set of 4 well-known children's books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study's objective was to evaluate the influence of their voice on their infant's feeding ability.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
3
|
Baseline Characteristics
A Clinical Trial of A Pacifier-Activated Music Player
Baseline characteristics by cohort
| Measure |
Books, PAL Group
n=46 Participants
PAL group
Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL).
Infants were randomly assigned by using a block system to control or intervention groups. Eligible siblings were enrolled into the same group because they shared the same room in the NICU. If 1 child received the PAM intervention while the other engaged in NNS, diffusion of treatment might occur; removal of the siblings' pacifier during the pacifier-activated lullaby (PAL) was not an alternative acceptable to nursing staff.
|
Books, No PAL Group
n=48 Participants
No PAL
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Birth weight, g, median
|
1495 grams
n=5 Participants
|
1405 grams
n=7 Participants
|
1450 grams
n=5 Participants
|
|
White matter injury
|
7 number of participants
n=5 Participants
|
9 number of participants
n=7 Participants
|
16 number of participants
n=5 Participants
|
|
Feeding rate at study start
|
0.6 ml/min
n=5 Participants
|
0.6 ml/min
n=7 Participants
|
0.6 ml/min
n=5 Participants
|
|
No. of oral feedings/d at study start
|
2 feedings per day
n=5 Participants
|
2 feedings per day
n=7 Participants
|
2 feedings per day
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, and Day 5Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention
Outcome measures
| Measure |
PAL Intervention
n=47 Participants
This group of participants received PAL intervention
|
No PAL Intervention
n=48 Participants
This group of participants did not receive PAL intervention
|
|---|---|---|
|
Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5)
|
2.0 mL/min
Interval 1.5 to 2.3
|
0.9 mL/min
Interval 0.5 to 1.2
|
SECONDARY outcome
Timeframe: day of hospital discharge (approximately 5-7 weeks)Description: Growth measures.
Outcome measures
| Measure |
PAL Intervention
n=46 Participants
This group of participants received PAL intervention
|
No PAL Intervention
n=48 Participants
This group of participants did not receive PAL intervention
|
|---|---|---|
|
Discharge Weight
|
2000 grams
Interval 1892.0 to 2228.0
|
1990 grams
Interval 1902.0 to 2120.0
|
SECONDARY outcome
Timeframe: Day 0, and Day 5Population: Specific data is no longer available, Outcome is described here: http://pediatrics.aappublications.org/content/133/3/462.full
Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: days from consent to dischargeDescription: Data on hospital stay was recorded from the chart. The participants were be followed for the duration of the hospital stay from the time of consent for participation to the time discharge from the NICU is documented.
Outcome measures
| Measure |
PAL Intervention
n=46 Participants
This group of participants received PAL intervention
|
No PAL Intervention
n=48 Participants
This group of participants did not receive PAL intervention
|
|---|---|---|
|
Hospital Length of Stay
|
41 days
Interval 25.0 to 69.0
|
50 days
Interval 31.0 to 86.0
|
SECONDARY outcome
Timeframe: Day 0 of the study to the date of first documented full oral feed (up to 70 days)Aim: Quantify the effect of the PAL intervention on efficiency of sucking and time to reaching full oral feeds in comparison to controls. Data on the number of days from Day 0 of the study to the date of first documented full oral feed, up to 70 days (or date of death from any cause) were be recorded from the chart.
Outcome measures
| Measure |
PAL Intervention
n=46 Participants
This group of participants received PAL intervention
|
No PAL Intervention
n=48 Participants
This group of participants did not receive PAL intervention
|
|---|---|---|
|
Number of Days to Full Oral Feeds
|
31 days
Interval 17.0 to 54.0
|
38 days
Interval 24.0 to 69.0
|
Adverse Events
PAL Group
Books, No PAL Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place