High-intensity and cycled phototherapy for newborn jaundice
Neonatal Hyperbilirubinemia - Phototherapeutic Treatment Strategies
This test compares higher-intensity and intermittent (cycled) phototherapy to standard continuous light to see which lowers bilirubin faster in newborns born at or after 33 weeks with non-hemolytic jaundice.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Sponsor | Regionshospital Nordjylland Government |
| Locations | 2 sites (Aalborg and 1 other locations) |
| Trial ID | NCT06702241 on ClinicalTrials.gov |
What this trial studies
This randomized multicenter trial will enroll 116 newborns (≥33+0 weeks gestation, ≥1800 g) with non-hemolytic hyperbilirubinemia above Danish treatment thresholds. All infants receive 12 hours of combined overhead phototherapy plus a biliblanket, with overhead irradiance set to 40, 55, or 70 µW/cm²/nm; the 70 µW/cm²/nm arm is split into continuous and cycled (intermittent) treatment, creating four groups. The trial is powered to compare bilirubin response across irradiance levels to define an upper effective limit and to compare cycled versus continuous delivery. Infants with rapidly rising bilirubin or other indications for immediate intensified therapy (multi-sided lights, exchange transfusion, or immunoglobulin) are excluded.
Who should consider this trial
Good fit: Newborns born at ≥33+0 weeks, weighing ≥1800 g, with serum bilirubin above the national treatment threshold and without signs of hemolysis or rapidly rising bilirubin are eligible.
Not a fit: Infants with jaundice within the first 24 hours of life, rapidly rising bilirubin suggestive of hemolysis, or those needing exchange transfusion or multi-sided intensive therapy are unlikely to benefit from the interventions tested here.
Why it matters
Potential benefit: If successful, the results could identify an optimal phototherapy dose and show whether intermittent treatment is as effective as continuous light, potentially shortening treatment or improving comfort.
How similar studies have performed: Smaller prior studies suggest cycled phototherapy can be as effective as continuous treatment, but evidence on benefits of very high irradiance levels remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 1 other locations
- Aalborg University Hospital, The Neonatal Department — Aalborg, Denmark (Recruiting)
- The North Denmark Regional Hospital, The Pediatric Department — Hjørring, Denmark (Recruiting)
Study contacts
- Study coordinator: Emil L Oehrstroem, MD
- Email: e.oehrstroem@rn.dk
- Phone: +45 24830384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.