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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511952
• Other study ID #: NICU Music Tx Interventions
• 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

• Prematurity
• RDS
• Sepsis
• SGA

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