Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

NARecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

October 31, 2026

Study Completion Date

January 1, 2027

Conditions
Hemolytic Disease of NewbornNeonatal Hyperbilirubinemia
Interventions
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.

Trial Locations (1)

42319

RECRUITING

Madinah maternity and children's hospital, Madinah

All Listed Sponsors
lead

Ministry of Health, Saudi Arabia

OTHER_GOV