NCT04365998

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

Use of "BUBOLight®" Device as an Innovative Phototherapy Device for the Treatment of Newborn's Jaundice. A Monocentric, Descriptive Pilot Study, for the Feasibility, Safety and Tolerance of the BUBOLight® Device

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

Summary

About 50% of full-term newborns and 80% of premature infants develop jaundice which is due to hyperbilirubinemia. In the majority of cases, jaundice disappears naturally without treatment within three weeks of birth, but the bilirubin level may remain too high, which can lead to a serious neurological disease: kernicterus. To avoid this, a therapeutic management must be instituted, and in some cases, one or more phototherapy sessions (PT) may be prescribed. The aim of this trial is to evaluate the safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy BUBOLight® included two removable strips of luminous textile incorporating optical fibers. 10 newborns requiring phototherapy, will be illuminated during four hours in one session of PT Bilirubin levels is taken at the start of phototherapy H0 and Controls are made at H+6 hours.

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
DEVICE	BUBOLight® Device	1 session of phototherapy with BUBOLight® device during 4 hours.

Timeline

• Start date: 2020-10-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-04-28
• Last updated: 2025-12-23

Locations

1 site across 1 country: France