Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

NCT04218318 | Recruiting

• 1 other identifier: H-03-M-084
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemolytic Disease of Newborn; Neonatal Hyperbilirubinemia

Keywords

Jaundice; Newborn; Hyperbilirubinemia; Rebound hyperbilirubinemia; Phototherapy; Hemolysis

Outcome Measures

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.

  28 days

Secondary Outcomes (7)

• Duration of phototherapy

  28 days

• Length of hospital stay

  28 days

• Adverse effects related to phototherapy

  28 days

• Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage

  28 days

• Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage

  28 days

Study Arms (2)

Low-threshold group

ACTIVE COMPARATOR

Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP phototherapy threshold.

Device: phototherapy

High-threshold group

ACTIVE COMPARATOR

Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate AAP phototherapy threshold.

Device: phototherapy

Interventions

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.

High-threshold group; Low-threshold group

Eligibility Criteria

• Age: 1 Hour - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Study Sites (1)

Madinah maternity and children's hospital

Madinah, 42319, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Erythroblastosis, Fetal; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia; Hemolysis

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Fatimah S Alhazmi, MD

  Ministry of Health, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatimah S Alhazmi, MD

CONTACT

00 966 54 0564141; f.alhazmi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cilinical fellow, Madinah Maternity and Children's Hospital, NICU

Model Details: A prospective open labeled randomized control trial

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 6, 2020
• Study Start: October 1, 2019
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

SA (1)