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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
Sponsor: Ministry of Health, Saudi Arabia
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.
Official title: Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Hour - 14 Days
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2019-10-01
Completion Date
2027-01-01
Last Updated
2025-01-03
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
Madinah maternity and children's hospital
Madinah, Saudi Arabia