Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Recruiting now · Not applicable

Conditions studied: Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia

In brief

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.

Key facts

Study ID

NCT04218318

Run by

Ministry of Health, Saudi Arabia

People needed

84

Starts

2019-10-01

Expected to finish

2027-01-01

Last updated by the study team

2025-01-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Madinah maternity and children's hospital — Madinah, Saudi Arabia (enrolling)

Full record on ClinicalTrials.gov

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