A Clinical Trial of A Pacifier-Activated Music Player (NICU PAL)

This study has been completed.
Sponsor:
Collaborators:
Vanderbilt Kennedy Center
Information provided by (Responsible Party):
Olena Chorna, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01600586
First received: May 9, 2012
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

NICU 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 NICU infants (Post-conceptional ages 34-36 weeks) in the Vanderbilt NICU. 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.


Condition Intervention
Prematurity
Device: Pacifier-Activated-Lullaby system (PAL).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Suck rate and efficiency: change from pre-test (Day 0) to post-test (Day 5) [ Time Frame: Day 0, and Day 5 ] [ Designated as safety issue: No ]
    Feeding rate when nippling is calculated by dividing the number of cc of nippled nutrition by time for consumption. Pattern of suck bursts between pauses will be counted 10 times for each feeding on 2 occasions: day prior to the study and last day of intervention.


Secondary Outcome Measures:
  • Weight, height, head circumference change from Pre-test (Day 0) to Post-test, (Day 5). [ Time Frame: Day 0, and Day 5 ] [ Designated as safety issue: No ]
    Description: Growth : Weight, height, head circumference

  • Change from Pre-test(Day 0)in Salivary cortisol levels to Post-test (Day 5) [ Time Frame: Day 0, and Day 5 ] [ Designated as safety issue: No ]
    Description: Stress: Salivary cortisol levels after 1 week of PAL in the intervention group

  • Hospital length of stay [ Time Frame: An expected avarage of 3 weeks ] [ Designated as safety issue: No ]
    Description: Data on hospital stay will be recorded from the chart. The participants will 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, an expected average of 3 weeks.

  • Number of days to full oral feeds [ Time Frame: Day 0 of the study to the date of first documented full oral feed ] [ Designated as safety issue: No ]
    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 (or date of death from any cause)will be recorded from the chart.


Enrollment: 100
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Books, PAL group
PAL group
Device: Pacifier-Activated-Lullaby system (PAL).
Pacifier-Activated-Lullaby system (PAL).
Other Name: Pacifier-Activated-Lullaby system (PAL).
No Intervention: Books, No PAL group
No 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.

Results: Ninety-four infants, (46 and 48 in the PAM intervention and control groups, respectively) completed the study. The intervention group had significantly increased oral feeding rate (2.0 vs. 0.9 ml/min, p < 0.001), oral volume intake (91.1 vs. 48.1 ml/kg/d, p = 0.001), oral feeds/day (6.5 vs. 4 p < 0.001), and faster-time-to-full oral feedings (31 vs. 38 d, p = 0.04 compared to controls. Weight gain and cortisol levels during the 5-day protocol were not different between groups. Average hospital stays were 20% shorter in the PAM group, but the difference was not significant (p = 0.07).

Conclusion: A PAM using mother's voice improves oral feeding skills in preterm infants without adverse effects on hormonal stress or growth.

  Eligibility

Ages Eligible for Study:   34 Weeks to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 CPAP,
  • infants determined to be unsafe to feed orally by the medical team or the feeding/speech specialists at Vanderbilt.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600586

Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Vanderbilt Kennedy Center
Investigators
Principal Investigator: Olena D Chorna, MM, MT-BC, NICU-MT Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Olena Chorna, Music Therapist, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01600586     History of Changes
Other Study ID Numbers: VKC 4-30-100-9622, UL1RR024975-01
Study First Received: May 9, 2012
Last Updated: December 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
NICU
Music therapy
Premature infant
Oral feeds
Non-Nutritive Sucking
Suck rate
Suck efficiency
Contingent music
Mother's voice

ClinicalTrials.gov processed this record on October 20, 2014