Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Last updated: January 1, 2025
Sponsor: Ministry of Health, Saudi Arabia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Treatment

phototherapy

Clinical Study ID

NCT04218318
H-03-M-084
  • Ages 1-14
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Major congenital abnormalities,

  • Surgical problems,

  • Direct hyperbilirubinemia

  • Sepsis

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: phototherapy
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
January 01, 2027

Study 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.

Connect with a study center

  • Madinah maternity and children's hospital

    Medina, 42319
    Saudi Arabia

    Active - Recruiting

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