BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's 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
University Hospital, Lille
15 participants
Oct 8, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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
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Interventions
1 session of phototherapy with BUBOLight® device during 4 hours.
Locations(1)
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NCT04365998