Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Launched by MINISTRY OF HEALTH, SAUDI ARABIA · Jan 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the best time to stop phototherapy, a common light treatment for newborns with a condition called hemolytic disease. This disease can cause high levels of a substance called bilirubin, which can lead to jaundice (yellowing of the skin and eyes). Researchers want to find out if stopping phototherapy at a lower bilirubin level (low-threshold) is safer than stopping at a higher level (high-threshold). They believe that using a lower level might help prevent a return of high bilirubin levels, known as rebound hyperbilirubinemia, in healthy term and late preterm babies.

To participate in this trial, infants must be healthy, born at least 35 weeks into the pregnancy, and diagnosed with hemolytic disease. They should show signs of hemolysis, which means their blood cells are breaking down. However, babies with major birth defects, surgical issues, certain types of high bilirubin levels that aren’t due to hemolytic disease, or infections will not be eligible. Parents can expect their babies to be monitored closely during the study to determine the safest approach for stopping treatment. The trial is currently recruiting participants, and it includes all genders, with babies aged from birth up to 14 days old.

Gender

ALL

Eligibility 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