Children Clinical Trial
— DRAPOfficial title:
Trial of a New Phototherapy Device for Treating Hyperbilirubinemia in Crigler-Najjar Patients : a New Concept
Evaluating the efficacity of a new device phototherapy by comparing it with conventional phototherapy. Jaundice occurs in many newborns, and is, in most cases benign, However, owing to the potential neurotoxicity of unconjugated bilirubin, newborns must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Treatment of jaundice in newborn relies on phototherapy, exposing their skin to light of a specific wavelength . Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. Light-emitting diodes (LEDs) are more recent sources which are power efficient, have a longer life and are portable with low heat production. Several technologies and devices are developed using LEDs and specially a compact system.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Years |
Eligibility |
Inclusion Criteria: - genetic diagnosis of Crigler Najjar disease - child whose height is between 60cm and 100cm - patients with follow-up in reference center, Exclusion Criteria: - opposition of parents - no social security insurance |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Antoine Béclère Hospital | Clamart |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinetic of blood Bilirubin level using the "DRAP" device (blood bilirubin concentration) | blood bilirubin concentration will be measured 2 times during phototherapy treatment (before and after phototherapy) | Before using "DRAP" device (H0), and after using (Hour12, Hour 36, Hour 48, Hour 60, Hour 72, Hour 84, Hour 96) |
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