Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospitals
New York, New York, United States, 10003
Actively Recruiting
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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