Determining safe levels to stop phototherapy for newborn jaundice
Official title: Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
Run by Ministry of Health, Saudi Arabia · NCT04218318 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Hour to 14 Days |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Ministry of Health, Saudi Arabia Government |
| Locations | 1 site (Madinah) |
| Status | Recruiting |
| Started | October 1, 2019 |
| Main results expected | October 31, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | January 3, 2025 |
| Trial ID | NCT04218318 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy term and late-preterm neonates over 35 weeks gestation diagnosed with hemolytic disease of the newborn.
✕Probably not a fit
Patients with major congenital abnormalities, surgical problems, direct hyperbilirubinemia, or sepsis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether a lower threshold for discontinuing phototherapy can reduce the rates of rebound hyperbilirubinemia in term and late preterm neonates suffering from hemolytic disease of the newborn. Participants will be divided into two groups: one will stop phototherapy at a higher threshold, while the other will stop at a lower threshold. The study aims to compare the safety and effectiveness of these two approaches in managing neonatal jaundice. The intervention involves administering phototherapy based on established guidelines and monitoring bilirubin levels closely.
Why it matters
Potential benefit: If successful, this approach could lead to safer management of jaundice in newborns, reducing the risk of rebound hyperbilirubinemia.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating a potential novel contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria: 1. positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or 2. HGB decline by 2g/dl within 24hour. Exclusion Criteria: * Major congenital abnormalities, * Surgical problems, * Direct hyperbilirubinemia * Sepsis
Where it's running
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Madinah maternity and children's hospital
Madinah, Saudi Arabia Recruiting
Study contacts
- Principal investigator: Fatimah S Alhazmi, MD — Ministry of Health, Saudi Arabia
- Study coordinator: Fatimah S Alhazmi, MD
- Email: f.alhazmi@hotmail.com
- Phone: 00 966 54 0564141
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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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.
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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.
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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.
-
High-intensity and cycled phototherapy for newborn jaundice
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.
-
Global registry for hemolytic disease of the fetus and newborn (HDFN)
This project will follow pregnant people at risk for HDFN to see how often their fetuses or newborns develop anemia while receiving standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.