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

Mount Sinai Health System

Status

Enrolling

Conditions

Prematurity

Treatments

Behavioral: Music Therapy Entrainment with Ocean Disc Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05223192

STUDY-21-01783

Details and patient eligibility

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.

Enrollment

118 estimated patients

Sex

All

Ages

24 to 37 weeks old

Volunteers

No Healthy Volunteers

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