Evaluation of Safety and Parental Satisfaction with the BUBOLight Phototherapy Device for Treating Newborn Jaundice

What this Trial Is About

Neonatal jaundice affects about half of full-term newborns and up to 80% of premature infants, caused by high bilirubin levels in the blood. While jaundice often resolves naturally within three weeks, elevated bilirubin can lead to serious brain disease called kernicterus. This trial aims to evaluate the safety and satisfaction of parents and healthcare staff using a new phototherapy device called BUBOLight, which uses luminous textile strips with optical fibers to treat newborn jaundice. The study involves 10 newborns requiring phototherapy who will receive one 4-hour session of phototherapy using the BUBOLight device. Bilirubin levels will be measured at the start of treatment and six hours later. The device is being evaluated as a new treatment approach for managing jaundice in newborns. Participants will be monitored for adverse events during and after phototherapy at baseline, 2 hours, and 4 hours. Additional assessments include blood and skin bilirubin levels, newborn pain and discomfort scores, and feedback from parents and healthcare providers about the device. The study is conducted until December 2026, with safety and satisfaction as key outcomes.

BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice