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Completed

NCT Number: NCT01600586

A Clinical Trial of A Pacifier-Activated Music Player

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

34 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pacifier-Activated-Lullaby system (PAL).

Device

Pacifier-Activated-Lullaby system (PAL).

Primary outcomes

  1. Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5)

    Time frame: Day 0, and 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

Secondary outcomes

  1. Discharge Weight

    Time frame: day of hospital discharge (approximately 5-7 weeks)

    Description: Growth measures.

  2. Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5)

    Time frame: Day 0, and Day 5

    Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group.

  3. Hospital Length of Stay

    Time frame: days from consent to discharge

    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.

  4. Number of Days to Full Oral Feeds

    Time frame: Day 0 of the study to the date of first documented full oral feed (up to 70 days)

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • Vanderbilt Kennedy Center

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 17, 2012
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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