NCT04218318

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Ministry of Health, Saudi Arabia · Other Government
• Sex: All
• Age: 1 Hour – 14 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hemolytic Disease of Newborn
• Neonatal Hyperbilirubinemia

Interventions

Type	Name	Description
DEVICE	phototherapy	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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2026-10-31
• Completion: 2027-01-01
• First posted: 2020-01-06
• Last updated: 2025-01-03

Locations

1 site across 1 country: Saudi Arabia