Description

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by hypoxemia, AOP is a major morbidity among preterm infants and a significant healthcare burden. AOP affects 70% of all early preterm births (<34 weeks gestational age) and nearly all at ≤ 28 weeks' gestation. In the United States in 2020, the total annual direct costs associated with AOP exceeded $12 billion. While there is no consensus for treating AOP, common interventions include positional techniques, caffeine citrate, manual tactile stimulation, and supplemental oxygen for hypoxemia. Caffeine citrate is the first line of therapy as it decreases apneic episodes and reduces the need for assisted ventilation. At recommended doses, caffeine has been proven safe and effective. However, in the sole trial supporting its FDA clearance, a majority of newborns treated with caffeine citrate continued to experience apnea events. In 2015, a clinical study using a stochastic vibrotactile stimulation (SVS) investigational device reported a 50% reduction in the number of apnea events. Prapela exclusively licensed the SVS technology of the investigational device and has demonstrated technical feasibility replicating the clinically critical stimulation in prototype incubator pads. The broad objective of this SBIR Fast-Track application is to generate the data and documentation necessary for FDA marketing clearance of a novel device to reduce apnea events in preterm newborns. To accomplish this objective, Prapela proposes four Specific Aims: 1) complete development of the SVS incubator pad, 2) demonstrate the safety of the device, 3) determine the clinical efficacy of the SVS incubator pad as an adjunctive therapy to concurrent pharmacological treatment in newborns with AOP, and 4) document the risk/benefit assessment of the device from clinicians caring for AOP patients. Efficacy will be established through a masked, randomized clinical trial with newborns of <33 weeks gestational age, with postmenstrual age (PMA) of <38 weeks at the time of enrollment. The control group will receive standard care only with caffeine citrate and respiratory support and an inert SVS device, while the intervention group will receive standard therapy concurrent with the Prapela SVS device. The primary outcome measure will be the mean number of apnea events in the three days after study entry, with a reduction in apnea events of 30% or more considered clinically significant. Questionnaires administered at the end of each experimental period to the clinicians present on the final shift will capture the risk/benefit assessment. The successful completion of the project will provide the data and documentation necessary for FDA marketing clearance and commercialization of our SVS incubator pad as a purpose-built device to improve clinical outcomes of preterm infants with AOP