Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 30 Days|
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Lille|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Thameur Rakza, MD|
|Principal Investigator Affiliation||University Hospital, Lille|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: BUBOLight® Device
Device: - BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.