BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
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.
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