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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223192
• Other study ID #: STUDY-21-01783
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Joanne V Loewy, DA, MT-BC, LCAT
• Phone: (212) 420-3484
• Email: joanne.loewy[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Behavioral:
• Music Therapy Entrainment with Ocean Disc Intervention
The studied intervention regards live entrainment with the ocean disc. Entrainment involves the use of an external stimulus, in the case of this study, an ocean disc instrument. Motion of the disc creates sounds in synchrony with the breathing of the infant and then in turn can control and influence the infant's regulation of the breath.

Locations

Country	Name	City	State
United States	Mount Sinai Hospitals	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate		14 days
Primary	Respiratory Rate		14 days
Primary	Oxygen-Saturation Level		14 days
Primary	Weight		14 days
Primary	Cerebral oxygen saturation	Cerebral oxygen saturation measured using NIRS	14 days