Actively Recruiting
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
Led by University Hospital, Lille · Updated on 2025-12-23
15
Participants Needed
1
Research Sites
320 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born after more than 35 weeks of gestation
- Presence of jaundice confirmed by bilirubin measurement
- Bilirubin level requiring phototherapy according to national guidelines
- Weight of at least 2.5 kilograms
- Infant judged in good health without perinatal asphyxia, antibiotic treatment, or respiratory disorders
- No feto-maternal rhesus or Kell incompatibility
You will not qualify if you...
- Newborn already treated with phototherapy
- Fever with body temperature above 37.8�C
- Bilirubin level equal to or exceeding 100 �mol/L above phototherapy indication
- Jaundice caused by hemolysis or functional/anatomical obstruction
- Minor relative of investigator
- Newborn requiring exchange transfusion
- Presence or family history of congenital erythropoietic porphyria
- Need for treatments other than phototherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hop Jeanne de Flandre Chu Lille
Lille, France, 59037
Actively Recruiting
Research Team
T
Thameur Rakza, MD
CONTACT
S
Serge Mordon, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here