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Behavioural Intervention

Womb Sound Recordings for Preterm Infant Respiratory Development

N/A
Recruiting
Led By Cynthia Bearer, MD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Awards & highlights

Study Summary

This trialstudies how sound exposure can affect brain development in premature babies.

Who is the study for?
This trial is for preterm infants born between 29-33 weeks of gestational age, who are now at a corrected age of 34 weeks and not on high-level respiratory support. Infants with congenital anomalies or those needing more intensive respiratory support are excluded.Check my eligibility
What is being tested?
The study is testing the effects of playing womb sound recordings to these preterm infants to see if it helps mature their brain's breathing control areas.See study design
What are the potential side effects?
Since this intervention involves non-invasive sound exposure, there are no direct physical side effects expected from the womb recordings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 24 hour period of randomized blocks of womb sound recordings and ambient noise
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 24 hour period of randomized blocks of womb sound recordings and ambient noise for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
body motion
bradycardia
cardiorespiratory events
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Womb sound recordings followed by ambient noiseExperimental Treatment1 Intervention
At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of commercially available womb sounds followed by ambient noise over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise.
Group II: Ambient noise followed by Womb soundExperimental Treatment1 Intervention
At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of ambient noise followed by commercially available womb sounds over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise.

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
300 Previous Clinical Trials
246,603 Total Patients Enrolled
Cynthia Bearer, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Womb Sound Recordings (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05298748 — N/A
Primary Apnea of Prematurity Research Study Groups: Ambient noise followed by Womb sound, Womb sound recordings followed by ambient noise
Primary Apnea of Prematurity Clinical Trial 2023: Womb Sound Recordings Highlights & Side Effects. Trial Name: NCT05298748 — N/A
Womb Sound Recordings (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05298748 — N/A
~7 spots leftby Dec 2024
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