Actively Recruiting
Newborn Jaundice - An Investigation of Different Approaches to Light Therapy
Led by Regionshospital Nordjylland · Updated on 2025-11-20
116
Participants Needed
2
Research Sites
250 weeks
Total Duration
On this page
Sponsors
R
Regionshospital Nordjylland
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Newborn Jaundice - An Investigation of Different Approaches to Light Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns with high bilirubin levels above the treatment threshold according to Danish Pediatric Society guidelines
- Birth weight greater than 1800 grams
- Gestational age older than 33 weeks and 0 days
You will not qualify if you...
- Jaundice appearing within the first 24 hours of life
- Rapidly increasing bilirubin levels indicating possible pathology or hemolysis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Aalborg University Hospital, The Neonatal Department
Aalborg, Denmark, 9000
Actively Recruiting
2
The North Denmark Regional Hospital, The Pediatric Department
Hjørring, Denmark, 9800
Actively Recruiting
Research Team
E
Emil L Oehrstroem, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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