A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
1 other identifier
interventional
272
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 16, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedMarch 24, 2015
March 1, 2015
3.9 years
January 16, 2012
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effects of live music intervention on premature baby function
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 Outcomes (1)
Vitals
10 mins before, during and after intervention
Study Arms (3)
Music intervention- SGA
ACTIVE COMPARATORInfants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Music Intervention- RDS
ACTIVE COMPARATORInfants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Music Intervention- Sepsis
ACTIVE COMPARATORInfants randomly assigned to receive one of three interventions-randomized for the AM or PM
Interventions
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
Eligibility Criteria
You may qualify if:
- Premature infants diagnosed with SGA, RDS and/or Sepsis \>32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing
You may not qualify if:
- Infants with diagnoses other than the above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne V Loewy, DA, MT-BC, LCAT
Beth Israel Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2012
First Posted
January 19, 2012
Study Start
January 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 24, 2015
Record last verified: 2015-03