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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joanne Loewy, Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01511952
First received: January 16, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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, sleected 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.


Condition Intervention
Prematurity
Sepsis
SGA
RDS
 Other: Music Intervention
Other: Music

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • The effects of live music intervention on premature baby function [ Time Frame: over two weeks intervention periods ] [ Designated as safety issue: No ]
    Infants function according to flow sheet and in cumulative adminstration will be viewed with and without music therapy entrainment


Secondary Outcome Measures:
  • Vitals [ Time Frame: 10 mins before, during and after intervention ] [ Designated as safety issue: No ]
    The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured


Enrollment: 272
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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 basinette 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'
No Intervention: 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 basinette 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'
No Intervention: 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 basinette 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'

  Eligibility

Ages Eligible for Study:   32 Weeks to 40 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511952

Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Joanne V Loewy, DA, MT-BC, LCAT Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Joanne Loewy, Director, Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01511952     History of Changes
Other Study ID Numbers: NICU Music Tx Interventions
Study First Received: January 16, 2012
Last Updated: January 16, 2012
Health Authority: United States:Insitutonal Review Board

Keywords provided by Beth Israel Medical Center:
music therapy
entrainment
premature infants
live music intervention
parent preferred lullabies

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013