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Clinical Trials/NCT05223192
NCT05223192RecruitingNot Applicable

The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

Icahn School of Medicine at Mount Sinai1 site in 1 country120 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
1
Primary Endpoint
Heart Rate

Study Overview

Brief Summary

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
24 Weeks to 37 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
  • •Newborn is considered appropriate for clinically indicated music therapy

Exclusion Criteria

  • •Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)
  • •Infant of uncertain viability (gestation <23 weeks, birth weight <500 grams)
  • •Known or suspected genetic disorder (e.g., Trisomy 21)
  • •Identified hearing disorder

Arms & Interventions

Intervention group

Experimental

Participants in this group will receive the ocean disc music therapy entrainment intervention

Intervention: Music Therapy Entrainment with Ocean Disc Intervention (Behavioral)

Control group

No Intervention

Participants in this group will not receive any intervention

Outcomes

Primary Outcomes

Heart Rate

Time Frame: 14 days

Oxygen-Saturation Level

Time Frame: 14 days

Weight

Time Frame: 14 days

Respiratory Rate

Time Frame: 14 days

Cerebral oxygen saturation

Time Frame: 14 days

Cerebral oxygen saturation measured using NIRS

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joanne Loewy

Associate Clinical Professor

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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