Chinstrap for Sleep Apnea in Preterm Infants
(STRAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if a chin strap helps reduce low oxygen episodes in premature babies receiving CPAP or NIPPV (breathing support through the nose). The main question it aims to answer is:
Does wearing a chin strap during CPAP or NIPPV make low oxygen episodes shorter compared to not wearing one?
Researchers will compare the chin strap period to the no-chin-strap period to see if the chin strap shortens low oxygen episodes.
Participants will:
Be randomly assigned to wear the chin strap first or skip it first Wear a soft chin strap for 24 hours, then switch to no chin strap for 24 hours (or the reverse), with a 1-hour break in between Have continuous monitoring of oxygen levels, heart rate, and breathing throughout the 49-hour study
Who Is on the Research Team?
Colm P. Travers, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for premature babies who are having breathing problems like apnea or low oxygen episodes and are receiving breathing support through the nose (CPAP or NIPPV).Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Chinstrap
Trial Overview
The study tests if wearing a soft chin strap helps reduce low oxygen episodes in preterm infants on CPAP or NIPPV. Each baby will try both with and without the chin strap, switching after 24 hours.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Infants randomized to the BA sequence receive a 24-hour no-strap period (Period 1) followed by a 1-hour washout and then a 24-hour chin strap period (Period 2). During Period 1, standard CPAP/NIPPV is delivered without a chin strap. During Period 2, a soft chin strap (Neotech ChinStrap) is applied to maintain gentle mouth closure during CPAP/NIPPV.
Infants randomized to the AB sequence receive a 24-hour chin strap period (Period 1) followed by a 1-hour washout and then a 24-hour no-strap period (Period 2). During Period 1, a soft chin strap (Neotech ChinStrap) is applied to maintain gentle mouth closure during CPAP/NIPPV. During Period 2, standard CPAP/NIPPV is delivered without a chin strap.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
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