NCT01600586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

May 7, 2018

Completed
Last Updated

May 7, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

May 9, 2012

Results QC Date

December 11, 2015

Last Update Submit

April 4, 2018

Conditions

Prematurity

Keywords

Neonatal Intensive Care Unit (NICU)Music therapyPremature infantOral feedsNon-Nutritive SuckingSuck rateSuck efficiencyContingent musicMother's voice

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Discharge Weight

    day of hospital discharge (approximately 5-7 weeks)

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

    Day 0, and Day 5

  • Hospital Length of Stay

    days from consent to discharge

  • Number of Days to Full Oral Feeds

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

Study Arms (2)

Pacifier-Activated-Lullaby system (PAL)

EXPERIMENTAL

Pacifier-Activated-Lullaby system (PAL) group.

Device: Pacifier-Activated-Lullaby system (PAL).

No PAL group

NO INTERVENTION

No PAL. Standard of care procedures.

Interventions

Pacifier-Activated-Lullaby system (PAL).DEVICE

Pacifier-Activated-Lullaby system (PAL).

Pacifier-Activated-Lullaby system (PAL)

Eligibility Criteria

Age34 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Limitations and Caveats

PI left Vanderbilt, data obtained from publication http://pediatrics.aappublications.org/content/133/3/462.full

Results Point of Contact

Title
Olena Chorna
Organization
Vanderbilt University
olena.chorna@vanderbilt.edu
850-508-5571

Study Officials

  • Olena D Chorna, MM, MT-BC

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 17, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 7, 2018

Results First Posted

May 7, 2018

Record last verified: 2018-04

Locations

US(1)