BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
Recruiting
N/A
Interventional Study
Neonatal Jaundice
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 30 Days
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- University Hospital, Lille · Other
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About This Trial
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 cas…
Trial Locations
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Eligibility Criteria
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 ≥2.500…
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