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

Not Applicable

Completed

• Conditions: Sepsis; Prematurity; SGA; RDS
• Interventions: Other: Music Intervention; Other: Music

• Registration Number: NCT01511952
• Lead Sponsor: Beth Israel Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-19
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Music Intervention- Sepsis	Music	Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Music intervention- SGA	Music Intervention	Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Music Intervention- Sepsis	Music Intervention	Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Music intervention- SGA	Music	Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Music Intervention- RDS	Music Intervention	Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Music Intervention- RDS	Music	Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vitals	10 mins before, during and after intervention	The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured