Clinical trial NCT05223192: The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Official title: The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prematurity
Keywords: music therapy
ocean disc
prematurity
vital signs
cerebral oxygenation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 118
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate
timeFrame: 14 days
measure: Respiratory Rate
timeFrame: 14 days
measure: Oxygen-Saturation Level
timeFrame: 14 days
measure: Weight
timeFrame: 14 days
measure: Cerebral oxygen saturation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospitals
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne V Loewy, DA, MT-BC, LCAT
role: PRINCIPAL_INVESTIGATOR
References: