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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the 24 hour period of randomized blocks of womb sound recordings and ambient noise

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

246,548 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being considered for inclusion in the experiment?

"According to the terms of participation, infants from 1 week old up until 5 weeks old are qualified for enrollment."

Answered by AI

What is the current capacity of enrollees for this clinical trial?

"Yes, the information on clinicialtrials.gov reveals that this trial is recruiting participants at present. The study was initially published 16th September 2022 and last updated 12th December 2022. 34 patients need to be enrolled from one site in total."

Answered by AI

Is this experiment currently available to participants?

"Per information on clinicaltrials.gov, this clinical trial is in the process of enrolling participants as it was first shared on September 16th 2022 and last modified on December 12th 2022."

Answered by AI

Am I eligible to be a part of this medical experiment?

"This clinical study is open to 34 neonates who experience primary apnea of prematurity. The age range for applicants must be between 1 Week and 5 Weeks old, with a gestational age at birth ranging from 29-33 weeks."

Answered by AI

Recent research and studies

PediatricsJournal

The Effects of Music Therapy on Vital Signs, Feeding, and Sleep in Premature Infants

Loewy, Joanne, Kristen Stewart, Ann-Marie Dassler, Aimee Telsey, and Peter Homel. 2013. “The Effects of Music Therapy on Vital Signs, Feeding, and Sleep in Premature Infants”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2012-1367.

Journal of PerinatologyJournal

White, R D, J A Smith, M M Shepley, and on behalf of the Committee to Establish Recommended Standards for Newborn ICU Design. 2013. “Recommended Standards for Newborn ICU Design, Eighth Edition”. Journal of Perinatology. Springer Science and Business Media LLC. doi:10.1038/jp.2013.10.

clinicaltrials.govStudy

The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

2022. "The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05298748.