The FDA has granted a de novo clearance to a vibrating mattress pad for hospital bassinets, designed to stimulate rhythmic breathing in premature newborns who may be facing a serious medical condition.
Prapela’s device provides gentle, randomized movements that aim to trigger and regulate the brain’s control of breathing, without being strong enough to wake up the baby from sleep. Also usable within radiant warmers and incubators, its slight up-and-down movements mimic the manual tactile stimulation sometimes provided by nurses to help encourage breathing.
The vibrating pad previously received two separate breakthrough designations from the FDA, and it has been studied in treating apnea of prematurity as well as newborns that have been exposed to opioids during pregnancy. Both conditions can result in low blood oxygen levels.
Apnea is common among preterm births—where breathing pauses for periods longer than 20 seconds—affecting about 70% of those born before 34 weeks, and nearly all of those born at or before 28 weeks. Typical interventions include the physical positioning of the newborn, as well as doses of caffeine.
Meanwhile, in a randomized clinical trial of newborns with prenatal opioid exposure, published in JAMA Pediatrics, vibrations provided by the mattress pad led to fewer days in treatment and reductions in the doses of morphine needed to stave off withdrawal symptoms.
Prapela has estimated that apnea of prematurity affects 1.6 million newborns per year, costing U.S. hospitals $17 billion annually, and that its approach may provide the first new treatment in over two decades.
In 2023, the FDA issued a de novo green light to the makers of the Snoo motorized bassinet, for what the agency described as an over-the-counter “infant supine sleep system” designed to hold the baby in a safe sleeping position.