BUBOLight® phototherapy device for treating newborn 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
This will try the BUBOLight® textile-based phototherapy device on newborns with jaundice who need phototherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 30 Days |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04365998 on ClinicalTrials.gov |
What this trial studies
This single-center interventional pilot enrolls 10 newborns who require phototherapy for neonatal jaundice and treats each infant with the BUBOLight® device for a four-hour session. Total bilirubin is measured at the start of phototherapy (H0) and again six hours later (H+6) to monitor response. The trial's primary focus is device safety and satisfaction reported by parents and the healthcare team using removable luminous textile strips with optical fibers. The study is conducted at Hop Jeanne de Flandre, CHU Lille, in collaboration with Inserm.
Who should consider this trial
Good fit: Term or near-term newborns (>35 weeks gestation) weighing ≥2.5 kg with bilirubin levels that meet national criteria for phototherapy and judged in good clinical health are ideal candidates.
Not a fit: Newborns with hemolytic jaundice, very high bilirubin requiring exchange transfusion, prior phototherapy, fever >37.8°C, congenital porphyria, or other excluded conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, BUBOLight® could offer a comfortable, easy-to-use phototherapy option that may improve parent and staff satisfaction while treating neonatal jaundice.
How similar studies have performed: Conventional phototherapy is well established and effective, but textile-based or wearable phototherapy devices like BUBOLight® are relatively novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Hop Jeanne de Flandre Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Thameur Rakza, MD — University Hospital, Lille
- Study coordinator: Thameur Rakza, MD
- Email: thameur.rakza@chru-lille.fr
- Phone: 03 20 44 63 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.