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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

ConditionsHemolytic Disease of NewbornNeonatal Hyperbilirubinemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorMinistry of Health, Saudi Arabia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or

HGB decline by 2g/dl within 24hour.

Disqualifiers

Major congenital abnormalities,

Surgical problems,

Direct hyperbilirubinemia

Sepsis

Trial design

Design model

Parallel

Treatments tested in this trial

  • phototherapy

    Device

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Low-threshold groupActive comparator 1 intervention
Group B: High-threshold groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Duration of phototherapy

Duration of phototherapy

Time frame
28 days
2

Length of hospital stay

Length of hospital stay

Time frame
28 days
3

Adverse effects related to phototherapy

Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration

Time frame
28 days
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ministry of Health, Saudi Arabia

Lead sponsor

Source ClinicalTrials.gov
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