FDA Clears Innovative Vibrating Mattress Pad for Premature Newborns

The U.S. Food and Drug Administration (FDA) has granted de novo clearance to a groundbreaking medical device designed to stimulate breathing in premature newborns. Developed by Prapela, the vibrating mattress pad provides gentle, randomized movements to trigger and regulate the brain's control of breathing without disturbing the infant's sleep.

Addressing a Critical Need in Neonatal Care

Apnea of prematurity, a condition characterized by pauses in breathing lasting more than 20 seconds, affects approximately 70% of infants born before 34 weeks gestation and nearly all babies born at or before 28 weeks. This common complication has significant implications for neonatal health and hospital resources, with Prapela estimating that it impacts 1.6 million newborns annually and costs U.S. hospitals $17 billion each year.

The newly cleared device offers a novel approach to managing this condition, potentially providing the first new treatment option in over two decades. It can be used in various neonatal care settings, including hospital bassinets, radiant warmers, and incubators.

Clinical Evidence and Breakthrough Status

Prapela's vibrating mattress pad has demonstrated promising results in clinical trials, earning two separate breakthrough designations from the FDA. In addition to its application in apnea of prematurity, the device has shown efficacy in treating newborns exposed to opioids during pregnancy.

A randomized clinical trial published in JAMA Pediatrics focused on infants with prenatal opioid exposure. The study revealed that the vibrating mattress pad led to fewer days in treatment and reduced the doses of morphine required to manage withdrawal symptoms.

Technological Innovation in Infant Care

The Prapela device represents a technological advancement in neonatal care, mimicking the manual tactile stimulation traditionally provided by nurses to encourage breathing. Its gentle, up-and-down movements are carefully calibrated to stimulate the infant's respiratory system without causing wakefulness.

This clearance follows the FDA's 2023 approval of another innovative infant care product, the Snoo motorized bassinet. Described as an over-the-counter "infant supine sleep system," the Snoo is designed to maintain babies in a safe sleeping position.

As these new technologies enter the market, they promise to enhance the quality of care for vulnerable newborns and potentially reduce the burden on neonatal intensive care units.