Clinical trial NCT04218318: Safe Threshold to Discontinue Phototherapy in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemolytic Disease of Newborn
Neonatal Hyperbilirubinemia
Keywords: Jaundice
Newborn
Hyperbilirubinemia
Rebound hyperbilirubinemia
Phototherapy
Hemolysis
Lead sponsor: Ministry of Health, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2020-01-06
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective open labeled randomized control trial
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

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:

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

Exclusion Criteria:

* Major congenital abnormalities,
* Surgical problems,
* Direct hyperbilirubinemia
* Sepsis

Primary outcomes:
measure: Rebound hyperbilirubinemia
timeFrame: 28 days
Secondary outcomes:
measure: Duration of phototherapy
timeFrame: 28 days
measure: Length of hospital stay
timeFrame: 28 days
measure: Adverse effects related to phototherapy
timeFrame: 28 days
measure: Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage
timeFrame: 28 days
measure: Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
timeFrame: 28 days
measure: Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
timeFrame: 28 days
measure: Total Cost of NICU Care
timeFrame: 90 days
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Madinah maternity and children's hospital
Study officials:
affiliation: Ministry of Health, Saudi Arabia
name: Fatimah S Alhazmi, MD
role: PRINCIPAL_INVESTIGATOR
References: