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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:
ClinicalTrials.gov Identifier:
NCT01511952
First Posted: January 19, 2012
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Beth Israel Medical Center
  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, 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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants

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 ]
    Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment


Secondary Outcome Measures:
  • Vitals [ Time Frame: 10 mins before, during and after intervention ]
    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
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'

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   32 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511952


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

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01511952     History of Changes
Other Study ID Numbers: NICU Music Tx Interventions
First Submitted: January 16, 2012
First Posted: January 19, 2012
Last Update Posted: March 24, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications


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