Actively Recruiting

Phase 2
Phase 3
Age: 1Day - 14Days
All Genders
NCT06702241

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

Age: 1Day - 14Days
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Newborn Jaundice - An Investigation of Different Approaches to Light Therapy | DecenTrialz