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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• At time of birth, infant is \> 35 weeks gestation

• Presence of jaundice confirmed by measurement of bilirubin (transcutaneous bilirubinometer)

• Total bilirubinemia rate requiring phototherapy according to National Institute for Health and Clinical Excellence.

• Weight ≥2.500kg

• Judged in good health by the investigator following the clinical examination and the medical data (absence of perinatal asphyxia, antibiotic treatment, respiratory disorders)

• Absence of fœto-maternal rhesus incompatibility or Kell

Locations
Other Locations
France
Hop Jeanne de Flandre Chu Lille
RECRUITING
Lille
Contact Information
Primary
Thameur Rakza, MD
thameur.rakza@chru-lille.fr
03 20 44 63 87
Backup
Serge Mordon, PhD
serge.mordon@inserm.fr
Time Frame
Start Date: 2020-10-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 15
Treatments
Experimental: BUBOLight® Device
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov