N/A
N=100
A Clinical Trial of A Pacifier-Activated Music Player
Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT01600586 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) — 2.0; 0.9 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pacifier-Activated-Lullaby system (PAL). (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) |
2.0; 0.9 | — |
| SECONDARY Discharge Weight |
2000; 1990 | — |
| SECONDARY Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5) |
— | — |
| SECONDARY Hospital Length of Stay |
41; 50 | — |
| SECONDARY Number of Days to Full Oral Feeds |
31; 38 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01600586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.