NCT06702241 Newborn Jaundice - An Investigation of Different Approaches to Light Therapy
| NCT ID | NCT06702241 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Regionshospital Nordjylland |
| Condition | Neonatal Hyperbilirubinemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 116 participants in total. It began in 2025-01-14 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 * Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06702241 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 14 Days, studying Neonatal Hyperbilirubinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06702241 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06702241 currently recruiting?
Yes, NCT06702241 is actively recruiting participants. Contact the research team at e.oehrstroem@rn.dk for enrollment information.
Where is the NCT06702241 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Hjørring, Denmark.
Who is sponsoring the NCT06702241 clinical trial?
NCT06702241 is sponsored by Regionshospital Nordjylland. The trial plans to enroll 116 participants.