The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Recruiting now · Not applicable
Conditions studied: Prematurity
In brief
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.
Key facts
- Study ID
- NCT05223192
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 118
- Starts
- 2022-04-01
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2025-04-08
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
- Newborn is considered appropriate for clinically indicated music therapy
You may not qualify if…
- 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
Where it is running
- Mount Sinai Hospitals — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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