An interventional study of phototherapy in Hemolytic Disease of Newborn and Neonatal Hyperbilirubinemia, sponsored by Ministry of Health, Saudi Arabia. Recruiting at 1 site in Saudi Arabia. Open to participants aged 1 Hour to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Ministry of Health, Saudi Arabia · Not applicable, Interventional, and Prevention
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.
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.
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:
Exclusion Criteria:
Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP phototherapy threshold.
Device: phototherapy
Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate AAP phototherapy threshold.
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.
Rebound hyperbilirubinemia
Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold within 72 hours of phototherapy discontinuation of a neonate's first round of phototherapy treatment.
Time frame: 28 days
Duration of phototherapy
Duration of phototherapy
Time frame: 28 days
Length of hospital stay
Length of hospital stay
Time frame: 28 days
Adverse effects related to phototherapy
Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration
Time frame: 28 days
Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage
Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold between 3-7 days of phototherapy discontinuation of a neonate's first round of phototherapy treatment.
Time frame: 28 days
Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
Time frame: 28 days
Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
Number of participants of whome rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
Time frame: 28 days
Total Cost of NICU Care
Total Cost of NICU Care
Time frame: 90 days
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Erythroblastosis, Fetal
Ministry of Health, Saudi Arabia