Actively Recruiting

Phase Not Applicable
Age: 1Hour - 14Days
All Genders
Healthy Volunteers
ID04218318

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

Age: 1Hour - 14Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Frequently Asked Questions

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