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NCT Number: NCT05223192

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

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospitals

New York, 10003, United States

Location status: Recruiting

Location contact

Joanne V Loewy

PRINCIPAL_INVESTIGATOR

Joanne V Loewy, DA, LCAT, MT-BC

CONTACT

[email protected]

(212) 420-3484

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy Entrainment with Ocean Disc Intervention

Behavioral

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.

Primary outcomes

  1. Heart Rate

    Time frame: 14 days

  2. Respiratory Rate

    Time frame: 14 days

  3. Oxygen-Saturation Level

    Time frame: 14 days

  4. Weight

    Time frame: 14 days

  5. Cerebral oxygen saturation

    Time frame: 14 days

    Cerebral oxygen saturation measured using NIRS

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Barone

CONTACT

[email protected]

212 420-2704

Joanne V Loewy, DA, MT-BC, LCAT

CONTACT

[email protected]

(212) 420-3484

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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