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

RecruitingNAAges 24 Weeks - 37 WeeksAllIcahn School of Medicine at Mount Sinai
NCT05223192 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 inte

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📋 Eligibility rules (as published)
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
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What it tests

  • Music Therapy Entrainment with Ocean Disc Intervention
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Where

1 site
Mount Sinai Hospitals
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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