CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Pacifier-Activated-Lullaby system (PAL).device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01600586
NCT01600586N/ACompleted

A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants

Vanderbilt University Medical Center·interventional·Posted May 17, 2012·Updated May 7, 2018

In Brief

A clinical study evaluating Pacifier-Activated-Lullaby system (PAL). for Prematurity. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and decreased length of hospitalization. The investigators propose to test the hypothesis that a week-long PAL intervention can improve feeding skills and decrease stress compared to standard of care parental interactions in infants in the late preterm period. The investigators also hypothesize that these improvements will result in shorter hospital stays and increased growth in the intervention group. Our study design is a prospective randomized controlled trial design of 94 infants (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will receive a book library with one lullaby book and record her voice to the PAL, which the music therapist will then administer in 15-minute sessions for 5 consecutive days. The 47 participants in the control group will receive the same library but no recording will be made or PAL used. Outcomes measured will include time to full oral feeds, suck rate and efficiency, salivary cortisol levels before and after intervention, daily growth parameters and nutritional data, and hospital length of stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrematurity
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2012
Enrollment StartApr 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago

Interventions

Pacifier-Activated-Lullaby system (PAL).device

Pacifier-Activated-Lullaby system (PAL).