Study of the Prapela SVS Incubator Pad to Improve Breathing in Preterm Infants with Apnea of Prematurity

What this Trial Is About

Researchers are evaluating a new hospital incubator pad that provides stochastic vibrotactile stimulation SVS as a complementary treatment for apnea of prematurity AOP, a common condition in preterm infants where breathing stops for 20 seconds or more. This study aims to establish the safety, effectiveness, and clinical risks and benefits of this device, which could improve management of AOP beyond the current standard therapy of caffeine citrate. The study focuses on newborns born before 33 weeks gestational age and younger than 38 weeks postmenstrual age at enrollment. The study compares two groups one receiving standard therapy with caffeine citrate plus continuous SVS stimulation via the Prapela SVS incubator pad, and a control group receiving standard therapy with an inert pad that looks identical but does not vibrate. Treatment with the SVS pad continues until the infant is apnea-free for three days and less than two weeks from anticipated discharge, or until the clinician decides to stop. If apnea returns after stopping, treatment may be restarted. Follow-up surveys will be conducted by telephone at 1 and 2 years of age to assess neurological development. Participants will be monitored closely with clinical evaluations and questionnaires completed by clinicians to assess risks and benefits. The primary outcome is the change in apnea rate during 7 to 28 days of intervention, with secondary outcomes assessed at earlier time points. The study is randomized and single-masked, with safety and efficacy data gathered to support possible FDA clearance and future use of the SVS incubator pad as an adjunctive therapy to improve outcomes in preterm infants with AOP.

"Prapela® SVS Incubator Pad for Apnea of Prematurity