NCT04365998 BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
| NCT ID | NCT04365998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Neonatal Jaundice |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-10-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2020-10-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Thameur Rakza, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04365998 clinical trial?
This trial is open to participants of all sexes, up to 30 Days, studying Neonatal Jaundice. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04365998 currently recruiting?
Yes, NCT04365998 is actively recruiting participants. Contact the research team at thameur.rakza@chru-lille.fr for enrollment information.
Where is the NCT04365998 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04365998 clinical trial?
NCT04365998 is sponsored by University Hospital, Lille. The principal investigator is Thameur Rakza, MD at University Hospital, Lille. The trial plans to enroll 15 participants.