A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants

March 19, 2015 updated by: Beth Israel Medical Center
This is a multi-site study of 272 premature infants >32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. The live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. The infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Premature infants diagnosed with SGA, RDS and/or Sepsis >32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing

Exclusion Criteria:

Infants with diagnoses other than the above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Music intervention- SGA
Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Other: Music Intervention
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
Other: Music
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
Other Names:
  • Remo Ocean disc
  • Gato box
  • Music therapist's or Parent's preferred lullaby or 'Twinkle'
Active Comparator: Music Intervention- RDS
Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Other: Music Intervention
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
Other: Music
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
Other Names:
  • Remo Ocean disc
  • Gato box
  • Music therapist's or Parent's preferred lullaby or 'Twinkle'
Active Comparator: Music Intervention- Sepsis
Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Other: Music Intervention
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
Other: Music
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
Other Names:
  • Remo Ocean disc
  • Gato box
  • Music therapist's or Parent's preferred lullaby or 'Twinkle'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects of live music intervention on premature baby function
Time Frame: over two weeks intervention periods
Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment
over two weeks intervention periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitals
Time Frame: 10 mins before, during and after intervention
The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured
10 mins before, during and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Medical Center

Investigators

  • Principal Investigator: Joanne V Loewy, DA, MT-BC, LCAT, Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 16, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICU Music Tx Interventions

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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