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New treatment option for Neonatal Jaundice
Official title BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
ClinicalTrials.gov ID: NCT04365998
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 30
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 30 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.