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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

body motion

bradycardia

cardiorespiratory events

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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