Actively Recruiting
Safe Threshold to Stop Phototherapy in Term and Late Preterm Newborns with Hemolytic Disease of Newborn A Randomized Controlled Trial
Led by Ministry of Health, Saudi Arabia · Updated on 2025-01-03
84
Participants Needed
1
Research Sites
378 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best safe threshold to stop phototherapy in newborn babies who have hemolytic disease of the newborn, a condition that can cause high bilirubin levels. The study aims to compare whether stopping phototherapy at a lower bilirubin level versus a higher bilirubin level affects the chance of rebound hyperbilirubinemia, which is a return of high bilirubin levels after treatment. This trial focuses on full-term and late preterm infants, particularly those born at or after 35 weeks of gestation. The study divides newborns into two groups based on when phototherapy is discontinued: one group stops treatment when bilirubin levels are 50-100 micromol/L below the current standard threshold, and the other stops when levels are about 100 micromol/L below that threshold. Phototherapy is given according to American Academy of Pediatrics (AAP) guidelines, using intensified overhead blue LED lights or intensified 360-degree LED phototherapy if bilirubin levels approach critical exchange transfusion levels. Intravenous immunoglobulin (IVIG) treatment is provided for infants with isoimmune hemolytic disease who do not respond to phototherapy. Immediate exchange transfusion is started if bilirubin levels are above the exchange threshold or if there are signs of acute bilirubin encephalopathy. Participants will be closely monitored for rebound hyperbilirubinemia within 28 days after stopping phototherapy. The study includes regular bilirubin level checks and clinical assessments to evaluate safety and effectiveness of the lower versus higher phototherapy discontinuation thresholds. Researchers will track the need for further treatments such as IVIG or exchange transfusion. The total participation period covers the initial phototherapy treatment and follow-up assessments within the first month of life to ensure babies remain stable and safe after treatment ends.
CONDITIONS
Official Title
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy term and late-preterm neonates born at 35 weeks gestation or later with hemolytic disease of newborn
- Evidence of hemolysis defined by positive direct antiglobulin test and blood group incompatibility (ABO or Rh) or hemoglobin drop by 2 g/dl within 24 hours
You will not qualify if you...
- Major congenital abnormalities
- Surgical problems
- Direct hyperbilirubinemia
- Sepsis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Madinah maternity and children's hospital
Madinah, Saudi Arabia, 42319
Actively Recruiting
Research Team
F
Fatimah S Alhazmi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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