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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth RDS SGA Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

32 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention

Other

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

Music

Other

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'

Primary outcomes

The effects of live music intervention on premature baby function

Time frame: over two weeks intervention periods

Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment

Secondary outcomes

Vitals

Time frame: 10 mins before, during and after intervention

The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jan 19, 2012
Registry last updated: Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed