New Phototherapy Device to Treat Patients With Crigler-Najjar Disease

NCT02356978 | Unknown

• 1 other identifier: P140202
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crigler Najjar Syndrome; Children

Keywords

Rare disease; Crigler-Najjar disease; Paediatric; Experimental device

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Arm 1

EXPERIMENTAL

Each patient will be treated before using the active usual homemade device, and after using the experimental new "DRAP" device. This new sheet was designed by weaving optical fibers connected to LEDs ( "BROCHIER" Technology). The "LIGHTEX" technology ® is a principle of weaving mill of optical fibres with side lighting connected to LEDs and allowing to realize flexible or stiff bright surfaces with very weak congestions, low consumption and high life cycle. The energy illumination of this device varies between 3 and 4 mW / cm ² ( average 3,6 mW / cm ².)

Device: Arm1 homemade phototherapy treatment; Device: DRAP

Interventions

Arm1 homemade phototherapy treatment DEVICE

session of 10 or 12 hours phototherapy treatment using the homemade device during the first night and then the "DRAP" device during the next nights.

Arm 1

DRAP DEVICE

Arm 1

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• genetic diagnosis of Crigler Najjar disease
• child whose height is between 60cm and 100cm
• patients with follow-up in reference center,

You may not qualify if:

• opposition of parents
• no social security insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Antoine Béclère Hospital

Clamart, 92141, France

RECRUITING

MeSH Terms

Conditions

Crigler-Najjar Syndrome; Rare Diseases

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Hereditary; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• VINCENT GAJDOS, Professor

  AP-HP, Antoine Béclère Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VINCENT GAJDOS, Professor

CONTACT

+33 1 45 37 42 72; vincent.gajdos@abc.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 6, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2016-12

Locations

FR (1)