High-intensity and cycled phototherapy for newborn jaundice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Kangaroo Care by Mother or Nurse to Reduce Pain During Phototherapy in Newborns

  This study tests whether mother-administered or nurse-administered kangaroo care during a heel-stick procedure reduces pain in newborns with hyperbilirubinemia, compared with standard care.

  Recruiting Marmara University · Istanbul · NCT07761689

• Foot reflexology and massage for newborns receiving light therapy

  This trial tests whether foot reflexology or body massage, added to standard phototherapy, can help lower bilirubin levels and improve stability in newborns with indirect hyperbilirubinemia.

  Recruiting Aydin Adnan Menderes University · Kusadasi, Aydın · NCT07610811

• Breath carbon monoxide measurement to help manage newborn jaundice.

  This project tests whether measuring end-tidal carbon monoxide from a newborn's breath in the first three days can help guide jaundice care for full-term babies.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT07346976

• Using exhaled carbon monoxide to guide modified care for newborn hemolysis causing severe jaundice

  This trial will test whether adding a bedside exhaled-carbon monoxide (ETCOc) measurement to a modified diagnosis and treatment plan can help prevent brain damage in newborns with severe hyperbilirubinemia.

  Recruiting Early Phase 1 Women's Hospital School Of Medicine Zhejiang University · Hangzhou · NCT06832800

• Determining safe levels to stop phototherapy for newborn jaundice

  This study is testing if stopping light treatment for jaundice in newborns at a lower level is safer and helps prevent a return of high bilirubin levels compared to stopping at a higher level.

  Recruiting Ministry of Health, Saudi Arabia · Madinah · NCT04218318

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.