Actively Recruiting

Phase Not Applicable
Age: 1Hour - 14Days
All Genders
Healthy Volunteers
NCT04218318

Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Led by Ministry of Health, Saudi Arabia · Updated on 2025-01-03

84

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Who Can Participate

Age: 1Hour - 14Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy term and late-preterm neonates born at 35 weeks gestation or later with hemolytic disease of newborn
  • Evidence of hemolysis defined by positive direct antiglobulin test and blood group incompatibility (ABO or Rh) or hemoglobin drop by 2 g/dl within 24 hours
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Madinah maternity and children's hospital

Madinah, Saudi Arabia, 42319

Actively Recruiting

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Research Team

F

Fatimah S Alhazmi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn | DecenTrialz