A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Beth Israel Medical Center
- Enrollment
- 272
- Primary Endpoint
- The effects of live music intervention on premature baby function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 32 Weeks to 40 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Music intervention- SGA
Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Intervention: Music Intervention (Other)
Music Intervention- Sepsis
Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Intervention: Music (Other)
Music intervention- SGA
Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Intervention: Music (Other)
Music Intervention- RDS
Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Intervention: Music Intervention (Other)
Music Intervention- RDS
Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Intervention: Music (Other)
Music Intervention- Sepsis
Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Intervention: Music Intervention (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Vitals(10 mins before, during and after intervention)