Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: phototherapy.
- Who it may be relevant to
- Registry conditions: Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia. Basic parameters: 1 Hour — 14 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
Overview
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.
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 exc
Primary outcome measures
- Rebound hyperbilirubinemia [Time frame: 28 days]
Secondary outcome measures (7)
- Duration of phototherapy [Time frame: 28 days]
- Length of hospital stay [Time frame: 28 days]
- Adverse effects related to phototherapy [Time frame: 28 days]
- Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage [Time frame: 28 days]
- 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 [Time frame: 28 days]
- Total Cost of NICU Care [Time frame: 90 days]
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:
- positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
- HGB decline by 2g/dl within 24hour.
Exclusion criteria
- Major congenital abnormalities,
- Surgical problems,
- Direct hyperbilirubinemia
- Sepsis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Saudi Arabia · 1 center
- Madinah maternity and children's hospital — Madinah
Identifiers
NCT: NCT04218318 · H-03-M-084