BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
ConditionNeonatal Jaundice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorUniversity Hospital, Lille
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BUBOLight® Device
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital, Lille
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov