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NCT05223192 · ClinicalTrials.gov registry record · NA
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
A NA study of Prematurity, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT05223192 is a NA study of Prematurity that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 118 participants, below the 206-participant average among 21 other Prematurity trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05223192, a NA study of Prematurity, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Music Therapy Entrainment with Ocean Disc Intervention
Study Locations (1)
New York
- Mount Sinai Hospitals - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05223192
The ClinicalTrials.gov registry entry for NCT05223192 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 21 other Prematurity trials with a reported enrollment target (43% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prematurity appearing as the primary indexed condition, and to 1 intervention - of which Music Therapy Entrainment with Ocean Disc Intervention is the first listed.
NCT05223192 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05223192 about?
NCT05223192 is a clinical study titled "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 ...
What is the current status of trial NCT05223192?
This trial is currently recruiting. It is a NA study. The enrollment target is 118 participants. The study started on 2022-04-01. Estimated completion is 2026-03-31.
What conditions does trial NCT05223192 study?
This clinical trial studies the following conditions: Prematurity.
What interventions are being tested in trial NCT05223192?
The interventions under investigation include: Music Therapy Entrainment with Ocean Disc Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05223192?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05223192 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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