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Newborn Jaundice - An Investigation of Different Approaches to Light Therapy

RecruitingPhase 2, Phase 3Ages 1 Day - 14 DaysAllRegionshospital Nordjylland
NCT06702241 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 * Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis
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What it tests

  • Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light
  • Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light
  • Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light
  • Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light
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Where

2 sites
Aalborg University Hospital, The Neonatal Department
Aalborg, Denmark
The North Denmark Regional Hospital, The Pediatric Department
Hjørring, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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