University of Alabama at Birmingham
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
Premature infants commonly receive continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV) as respiratory support. A frequent and underappreciated problem during nasal CPAP/NIPPV is mouth opening, which disrupts the closed circuit needed for effective positive pressure transmission. This oral air leak reduces effective airway pressure, leads to loss of lung volume, increases work of breathing, and results in respiratory instability. Clinically, this manifests as intermittent hypoxemia (IH) - episodes of oxygen desaturation - and bradycardia. IH is high…
Inclusion Criteria: Gestational age less than 32 weeks at birth Less than 34 weeks postmenstrual age (PMA) at enrollment Receiving CPAP or NIPPV with PEEP of 5-10 cmH₂O FiO₂ 0.40 or less At least 72 hours of age Clinically stable, defined as no increase in respiratory support settings in the preceding 24 hours Exclusion Criteria: Major congenital anomalies Craniofacial abnormalities affecting chin strap fit or mouth closure Active seizures Imminent need for intubation as determined by the treating clinician Known or suspected chromosomal abnormalities Participation in another interventional…
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.
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