A Clinical Trial of A Pacifier-Activated Music Player

Completed · Not applicable

Conditions studied: Prematurity

In brief

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.

Key facts

Study ID

NCT01600586

Run by

Vanderbilt University Medical Center

People needed

100

Starts

2012-04-01

Expected to finish

2013-06-01

Last updated by the study team

2018-05-07

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All infants at 34 0/7 to 35 6/7 weeks post-conceptional age cared for in the Vanderbilt NICU who are receiving more than 50 % of their nutrition as enteral feeds, and are in individual rooms or in the room with their sibling.

You may not qualify if…

• infants on ventilators or Continuous Positive Airway Pressure (CPAP),
• infants determined to be unsafe to feed orally by the medical team or the feeding/speech specialists at Vanderbilt.

Where it is running

• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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