Newborn Jaundice - An Investigation of Different Approaches to Light Therapy
Recruiting
Phase 2
Phase 3
Interventional Study
Neonatal Hyperbilirubinemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 14 Days
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 116 (estimated)
- Sponsor
- Regionshospital Nordjylland · Government
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About This Trial
Background Neonatal jaundice affects about 60% of full-term newborns in their first week. If untreated, it can lead to permanent brain damage. In Denmark, 2-5% of newborns require phototherapy, the standard treatment. The maximum beneficial irradiance limit for phototherapy remains unclear. Furthermore, studies suggest that cycled phototherapy is as effective as continuous treatment.
This study a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Hyperbilirubinemia with a total serum bilirubin level above the limit of necessary treatment according to the Danish Pediatric Society's guidelines
* Birth weight \>1800g
* Gestational age \>33+0
Exclusion Criteria:
* Hyperbilirubinemia within the first 24 hours of life
* Ra…
Contacts