A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

Janssen Research & Development, LLC18 sites in 9 countries17 target enrollmentJanuary 16, 2019

ConditionsEarly Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)Erythroblastosis, Fetal

Overview

Phase: N/A
Intervention: Not specified
Conditions: Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)
Sponsor: Janssen Research & Development, LLC
Enrollment: 17
Locations: 18
Primary Endpoint: Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

Detailed Description

The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.

Registry

clinicaltrials.gov

Start Date

January 16, 2019

End Date

September 22, 2023

Last Updated

7 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)

Time Frame: GA Week 32 through GA Week 37

Secondary Outcomes

Percentage of Participants With Live Birth(Up to approximately GA Week 37)
Number of days of phototherapy required by neonate(Post-Birth through Age 3 Months)
Number of Simple Transfusions Required by Neonate in the First 3 Months of Life(Post-Birth through Age 3 Months)
Percentage of Participants at GA Week 24 Without an IUT(Week 24)
GA at First IUT(Up to approximately GA Week 37)
Percentage of Neonates Requiring Exchange Transfusions(Post-Birth through Age 3 Months)
Number of IUTs Required(Up to approximately GA Week 37)
Percentage of Participants With Fetal Hydrops(Post-Birth through Age 3 Months)
Percentage of Neonates Requiring Phototherapy(Post-Birth through Age 3 Months)
Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life(Post-Birth through Age 3 Months)