Actively Recruiting

Phase Not Applicable
Age: 24Weeks - 37Weeks
All Genders
NCT05223192

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-08

118

Participants Needed

1

Research Sites

208 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 24Weeks - 37Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
  • Newborn is considered appropriate for clinically indicated music therapy
Not Eligible

You will not qualify if you...

  • Infant not expected to survive 24 hours from the time of study entry
  • Infant of uncertain viability (gestation less than 23 weeks, birth weight less than 500 grams)
  • Known or suspected genetic disorder (e.g., Trisomy 21)
  • Identified hearing disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospitals

New York, New York, United States, 10003

Actively Recruiting

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Research Team

J

Joanne V Loewy, DA, MT-BC, LCAT

CONTACT

E

Elizabeth Barone

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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