A Clinical Trial of A Pacifier-Activated Music Player

Study Overview
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Brief Summary
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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.

Detailed Description
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Objectives: We conducted a randomized trial to test the hypothesis that the mother's voice played through a pacifier-activated music (PAM) player during nonnutritive sucking would improve the development of sucking ability and promote more effective oral feeding in preterm infants. Methods: Preterm infants between 34 0/7 and 35 6/7 weeks postmenstrual age, including those with brain injury, who were taking at least half their feedings enterally and less than half orally, were randomly assigned to receive 5 daily 15-minute sessions of either PAM with mother's recorded voice or no PAM, along with routine nonnutritive sucking and maternal care in both groups. Assignment was masked to the clinical team.

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

Conditions
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Prematurity

Intervention / Treatment
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* Device: Pacifier-Activated-Lullaby system (PAL).


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pacifier-Activated-Lullaby system (PAL)<br>Pacifier-Activated-Lullaby system (PAL) group. | Device: Pacifier-Activated-Lullaby system (PAL).<br>* Pacifier-Activated-Lullaby system (PAL).<br>|
| No Intervention: No PAL group<br>No PAL. Standard of care procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) | 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 | Day 0, and Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge Weight | Description: Growth measures. | day of hospital discharge (approximately 5-7 weeks) | 
| Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5) | Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group. | Day 0, and Day 5 | 
| Hospital Length of Stay | Description: 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. | days from consent to discharge | 
| Number of Days to Full Oral Feeds | 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. | Day 0 of the study to the date of first documented full oral feed (up to 70 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Intensive Care Unit (NICU), Music therapy, Premature infant, Oral feeds, Non-Nutritive Sucking, Suck rate, Suck efficiency, Contingent music, Mother's voice