This trial is completed!
Search for a recruiting clinical trial for your condition
You can access this
clinical trial
if you have
and you are
between 34 and 36
years old
The phase for this study is not defined.
Show me locations

The purpose

NICU 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 NICU infants (Post-conceptional ages 34-36 weeks) in the Vanderbilt NICU. 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.

Provided treatments

  • Device: Pacifier-Activated-Lullaby system (PAL).
Tris trial is registered with FDA with number: NCT01600586. The sponsor of the trial is Vanderbilt University Medical Center and it is looking for 100 volunteers for the current phase.
Official trial title:
A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants