When exposed to opioids before birth, some newborns experience painful withdrawal symptoms, including frantic breathing or tachypnea (>60 breaths/minute). Prapela has received FDA Breakthrough Device Designation for Neonatal Abstinence Syndrome (NAS). Thanks to grants from the National Institute on Drug Abuse (NIDA), the FDA is currently reviewing our De Novo submission for marketing clearance of the Prapela bassinet pad to treat newborns suffering from NAS.
Apnea of Prematurity (AOP)
When preterm newborns stop breathing for 20 seconds or more, caffeine is prescribed more than any other treatment. Even after caffeine, most newborns continue to experience apneas several times a day. Prapela has been awarded FDA Breakthrough Device Designation and a grant from the NIH Blueprint MedTech program to gain FDA clearance on our pad to improve the treatment of AOP.
Common breathing issues
Many of the most common breathing issues treated in neonatal intensive care units lead to the use of supplemental oxygen to reverse hypoxia. These issues include Respiratory Syncytial Virus (RSV), Bronchopulmonary Dysplasia (BPD), and Respiratory Distress Syndrome (RDS). A study, soon to be published, found improved oxygen uptake in ventilated newborns while lying on a pad with Prapela's vibration.