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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Recruiting
14 years and younger
All
Phase N/A

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Overview

We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.

Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.

Description

Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate 2004 AAP phototherapy threshold, whereas neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP threshold.

Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.

Eligibility

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

Study details
    Hemolytic Disease of Newborn
    Neonatal Hyperbilirubinemia

NCT04218318

Ministry of Health, Saudi Arabia

15 October 2025

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