Status:
RECRUITING
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Neonatal Jaundice
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Newborn already treated with phototherapy
- Febrile state with body temperature \> 37.8°C
- Total bilirubinaemia level is equal or excess 100 μmol / L of the indication of phototherapy.
- Patient whose jaundice is due to haemolysis, obstruction functional or anatomical.
- Minor relative
- Newborn requiring exchange transfusion
- Newborn with congenital erythropoietic porphyria or a family history of porphyria.
- Patient requiring treatment other than phototherapy
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04365998
Start Date
October 8 2020
End Date
December 1 2026
Last Update
December 23 2025
Active Locations (1)
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1
Hop Jeanne de Flandre Chu Lille
Lille, France, 59037