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

University Hospital, Lille

Status: Enrolling

Conditions: Neonatal Jaundice

Treatments: Device: BUBOLight® Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04365998

2019-A01417-50 (Other Identifier)

2018_68

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

BUBOLight® Device

Experimental group

Treatment:

Device: BUBOLight® Device