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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prematurity Sepsis SGA RDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Music intervention- SGA

Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM

Group Type ACTIVE_COMPARATOR

Music Intervention

Intervention Type OTHER

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

Music

Intervention Type OTHER

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

Music Intervention- RDS

Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM

Group Type ACTIVE_COMPARATOR

Music Intervention

Intervention Type OTHER

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

Music

Intervention Type OTHER

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

Music Intervention- Sepsis

Infants randomly assigned to receive one of three interventions-randomized for the AM or PM

Group Type ACTIVE_COMPARATOR

Music Intervention

Intervention Type OTHER

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

Music

Intervention Type OTHER

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

Interventions

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Music Intervention

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

Intervention Type OTHER

Music

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

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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