Clinical trial NCT01600586: A Clinical Trial of A Pacifier-Activated Music Player
Official title: A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Neonatal Intensive Care Unit (NICU)
Music therapy
Premature infant
Oral feeds
Non-Nutritive Sucking
Suck rate
Suck efficiency
Contingent music
Mother's voice
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt Kennedy Center
name: National Center for Research Resources (NCRR)
First posted: 2012-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 34
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5)
timeFrame: Day 0, and Day 5
Secondary outcomes:
measure: Discharge Weight
timeFrame: day of hospital discharge (approximately 5-7 weeks)
measure: Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5)
timeFrame: Day 0, and Day 5
measure: Hospital Length of Stay
timeFrame: days from consent to discharge
measure: Number of Days to Full Oral Feeds
timeFrame: Day 0 of the study to the date of first documented full oral feed (up to 70 days)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Olena D Chorna, MM, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: