A Clinical Trial of A Pacifier-Activated Music Player

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

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 Overview

• Status: Completed
• Conditions: Prematurity
• Intervention / Treatment: Device: Pacifier-Activated-Lullaby system (PAL).

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Center for Research Resources (NCRR); Vanderbilt Kennedy Center
• Investigators: Principal Investigator: Olena D Chorna, MM, MT-BC, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Music therapy; Premature infant; Mother's voice; Neonatal Intensive Care Unit (NICU); Oral feeds; Non-Nutritive Sucking; Suck rate; Suck efficiency; Contingent music
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: VKC 4-30-100-9622; UL1RR024975-01 (U.S. NIH Grant/Contract)