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NCT Number: NCT04218318

Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rebound hyperbilirubinemia

    Time frame: 28 days

    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.

Secondary outcomes

  1. Duration of phototherapy

    Time frame: 28 days

    Duration of phototherapy

  2. Length of hospital stay

    Time frame: 28 days

    Length of hospital stay

  3. Adverse effects related to phototherapy

    Time frame: 28 days

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

  4. Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage

    Time frame: 28 days

    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.

  5. 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 phototherapy threshold by ≥35 µmol/L after phototherapy stoppage

  6. Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage

    Time frame: 28 days

    Number of participants of whome rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage

  7. Total Cost of NICU Care

    Time frame: 90 days

    Total Cost of NICU Care

Study contacts

Contact information is provided by the study sponsor or research team.

Fatimah S Alhazmi, MD

CONTACT

[email protected]

00 966 54 0564141

Sponsors and collaborators

Lead sponsor

Ministry of Health, Saudi Arabia

Other Gov

Registry information

Official study title

Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2020
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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