Clinical trial Recruiting at 1 site Interventional Ages 1 Hour to 14 Days

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.

More Neonatal Hyperbilirubinemia trials

Quick facts

Study typeInterventional
Ages1 Hour to 14 Days
SexAll
Enrollment84 (estimated)
SponsorMinistry of Health, Saudi Arabia
Government
Locations1 site (Madinah)
StatusRecruiting
StartedOctober 1, 2019
Main results expectedOctober 31, 2026
Study endsJanuary 1, 2027
Registry record updatedJanuary 3, 2025
Trial IDNCT04218318 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

  • Madinah maternity and children's hospital
    Madinah, Saudi Arabia
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.