Newborn Jaundice - An Investigation of Different Approaches to Light Therapy
Recruiting now · Phase 2/Phase 3
Conditions studied: Neonatal Hyperbilirubinemia
In brief
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 aims to investigate the efficacy of elevating the irradiance of intensive phototherapy treatment regimens. This is to evaluate the dose-response relationship. Furthermore, the study aims to compare intermittent phototherapy to continuous phototherapy. Methods: In a clinical randomized multicenter trial 116 newborns with non-hemolytic hyperbilirubinemia, gestational age \>33+0, weight \>1800g and no other significant neonatal diagnose will be randomized. All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW/cm2/nm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW/cm2/nm. Parental experiences during treatment will be examined through a survey post treatment. The study has been approved by the Regional Research Ethics Committee. Perspectives: Understanding the dose-response relationship of phototherapy will give an insight in the most effective way of treating neonatal jaundice. Intermittent therapy, if proven non-inferior, could facilitate more intimacy in the parent-infant relationship as well as benefits in initiating breastfeeding
Key facts
- Study ID
- NCT06702241
- Run by
- Regionshospital Nordjylland
- People needed
- 116
- Starts
- 2025-01-14
- Expected to finish
- 2029-11-01
- Last updated by the study team
- 2025-11-20
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Hyperbilirubinemia within the first 24 hours of life
- Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis
Where it is running
- Aalborg University Hospital, The Neonatal Department — Aalborg, Denmark (enrolling)
- The North Denmark Regional Hospital, The Pediatric Department — Hjørring, Denmark (enrolling)
Full record on ClinicalTrials.gov
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