Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joanne Loewy, Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01511952
First received: January 16, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 16, 2012
January 16, 2012
January 2007
December 2010   (final data collection date for primary outcome measure)
The effects of live music intervention on premature baby function [ Time Frame: over two weeks intervention periods ] [ Designated as safety issue: No ]
Infants function according to flow sheet and in cumulative adminstration will be viewed with and without music therapy entrainment
Same as current
No Changes Posted
Vitals [ Time Frame: 10 mins before, during and after intervention ] [ Designated as safety issue: No ]
The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured
Same as current
Not Provided
Not Provided
 
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Not Provided

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, sleected 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Prematurity
  • Sepsis
  • SGA
  • RDS
  • Other: Music Intervention
    Applied by randomization-live at basinette in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
  • Other: Music
    Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
    Other Names:
    • Remo Ocean disc
    • Gato box
    • Music therapist's or Parent's preferred lullaby or 'Twinkle'
  • No Intervention: Music intervention- SGA
    Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
    Interventions:
    • Other: Music Intervention
    • Other: Music
  • No Intervention: Music Intervention- RDS
    Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
    Interventions:
    • Other: Music Intervention
    • Other: Music
  • No Intervention: Music Intervention- Sepsis
    Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
    Interventions:
    • Other: Music Intervention
    • Other: Music
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
32 Weeks to 40 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01511952
NICU Music Tx Interventions
Yes
Joanne Loewy, Beth Israel Medical Center
Beth Israel Medical Center
Not Provided
Principal Investigator: Joanne V Loewy, DA, MT-BC, LCAT Beth Israel Medical Center
Beth Israel Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP