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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Sponsor: University of Alabama at Birmingham
Summary
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
Key Details
Gender
All
Age Range
3 Days - 3 Months
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2027-01-15
Completion Date
2027-09-30
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Chinstrap
A soft, commercially available chin strap (Neotech ChinStrap, Neotech Products LLC) applied to maintain gentle mouth closure during CPAP/NIPPV in preterm infants. Size is selected based on head circumference measurement. The device is made of soft, breathable NeoFoam material, is latex-free, and is for single patient use. It is applied by nursing staff and assessed hourly for proper positioning and skin integrity.
Locations (1)
University of Alabama at Birmingha
Birmingham, Alabama, United States