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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01511952
Other study ID # NICU Music Tx Interventions
Secondary ID
Status Completed
Phase N/A
First received January 16, 2012
Last updated March 19, 2015
Start date January 2007
Est. completion date December 2010

Study information

Verified date March 2015
Source Beth Israel Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 32 Weeks to 40 Weeks
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Music Intervention
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
Music
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Vitals The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured 10 mins before, during and after intervention No
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