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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01511952
Enrollment
272
Registered
2012-01-19
Start date
2007-01-31
Completion date
2010-12-31
Last updated
2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, RDS, Sepsis, SGA

Keywords

music therapy, entrainment, premature infants, live music intervention, parent preferred lullabies

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.

Interventions

OTHERMusic Intervention

Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies

OTHERMusic

Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'

Sponsors

Beth Israel Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 40 Weeks
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

Design outcomes

Primary

MeasureTime frameDescription
The effects of live music intervention on premature baby functionover two weeks intervention periodsInfants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment

Secondary

MeasureTime frameDescription
Vitals10 mins before, during and after interventionThe HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026