RecruitingNot ApplicableNCT04218318

Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial

Sponsor

Ministry of Health, Saudi Arabia

Enrollment

84 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Neonatal hyperbilirubinemia Hemolytic Disease of Newborn

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

Min Age: 1 HourMax Age: 14 Days

Inclusion Criteria3

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:
positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
HGB decline by 2g/dl within 24hour.

Exclusion Criteria4

Major congenital abnormalities,
Surgical problems,
Direct hyperbilirubinemia
Sepsis

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Interventions

DEVICEphototherapy

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.