BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice (NCT04365998) | Clinical Trial Compass
RecruitingNot Applicable
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
France15 participantsStarted 2020-10-08
Plain-language 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.
Who can participate
Age range
30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of related adverse events (Safety)
Timeframe: at the begin of phototherapy (baseline, H0)
2
Number of related adverse events (Safety)
Timeframe: at 2 hours after the beginning of phototherapy (H2)
3
Number of related adverse events (Safety)
Timeframe: at the end of phototherapy exposure (H4)