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

Beth Israel Lahey Health

Status: Completed

Conditions: Prematurity; SGA; RDS; Sepsis

Treatments: Other: Music; Other: Music Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01511952

NICU Music Tx Interventions

Details and patient eligibility

About

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.

Enrollment: 272 patients

Sex: All

Ages: 32 to 40 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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272 participants in 3 patient groups

Music intervention- SGA

Active Comparator group

Description:

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

Treatment:

Other: Music Intervention

Other: Music

Music Intervention- RDS

Active Comparator group

Description:

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

Treatment:

Other: Music Intervention

Other: Music

Music Intervention- Sepsis

Active Comparator group

Description:

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

Treatment:

Other: Music Intervention

Other: Music