RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05223192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Weeks to 37 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
  2. * Newborn is considered appropriate for clinically indicated music therapy
  1. * 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)
  2. * Infant of uncertain viability (gestation \<23 weeks, birth weight \<500 grams)
  3. * Known or suspected genetic disorder (e.g., Trisomy 21)
  4. * Identified hearing disorder

Contacts and Locations

Study Contact

Joanne V Loewy, DA, MT-BC, LCAT
CONTACT
(212) 420-3484
joanne.loewy@mountsinai.org
Elizabeth Barone
CONTACT
212 420-2704
Elizabeth.Barone@mountsinai.org

Principal Investigator

Joanne V Loewy, DA, MT-BC, LCAT
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Hospitals
New York, New York, 10003
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Joanne V Loewy, DA, MT-BC, LCAT, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-04-15
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • music therapy
  • ocean disc
  • prematurity
  • vital signs
  • cerebral oxygenation

Additional Relevant MeSH Terms

  • Prematurity