Study of PIMUN Device to Reduce Intermittent Hypoxia and Apnea in Preterm Infants Under 30 Days Old

What this Trial Is About

Researchers are studying whether the PIMUN medical device can reduce intermittent hypoxemia in preterm infants born between 24 and 34 weeks of gestational age. This trial focuses on babies younger than 30 days with apnea of prematurity. The study aims to find out if PIMUN lowers the time oxygen levels drop below 90% and to evaluate its safety during use. Participants will be randomly assigned to use PIMUN or receive usual care without PIMUN for 48 hours in a crossover design. PIMUN is a soft garment with an inflatable dorsal chamber that delivers pulsatile stimulation to encourage breathing. During each 48-hour period, infants will have continuous heart and breathing monitoring, brain oxygen level checks by near-infrared spectroscopy, and 4 to 5 hours of sleep studies. Blood and urine samples will be collected to measure oxidative stress. Throughout the trial, researchers will monitor oxygen saturation, heart rate, apnea events, sleep quality, and safety indicators like skin condition and comfort. They will compare outcomes between periods with and without PIMUN. The main measurement is total time with oxygen saturation under 90%. The study also tracks deeper oxygen drops, apnea numbers, and need for breathing support. Participation lasts through both 48-hour intervention periods with monitoring and sample collection.

Efficacy of PIMUN by Reducing Intermittent Hypoxia Events