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NCT07194070 · ClinicalTrials.gov registry record
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
A clinical trial of Hemolytic Disease of the Fetus and Newborn, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- 175
- Enrollment target
- 10
- Study locations
NCT07194070: Recruiting study of Hemolytic Disease of the Fetus and Newborn, sponsored by Janssen Research & Development.
NCT07194070 is a study of Hemolytic Disease of the Fetus and Newborn that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 175 participants. The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07194070, a study of Hemolytic Disease of the Fetus and Newborn, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- 175 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby.
Primary Outcome
Percentage of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period will be reported. Hydrops fetalis is defined as the presence of greater than or equal to (\>=) 2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater than \[\>\] 5 millimeter \[mm\]). Post-menstrual age (PMA) is the time ela
Conditions Studied
Interventions
- OTHER Standard of Care
Study Locations (10)
Other
- The Royal Women's Hospital - Parkville
- Mater Misericordiae Ltd - South Brisbane
- Interdiszip Schwerpunkt fur Hamostaseologie - Giessen
- Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico - Milan
- Fondazione Policlinico Universitario A Gemelli IRCCS - Roma
- Birmingham Women's Hospital - Birmingham
Indiana
- Riley Children s Hospital - Indianapolis
Ohio
- University of Cincinnati - Cincinnati
Oregon
- Oregon Health And Science University - Portland
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2025-02-20 |
| Est. Completion | 2030-09-30 |
What NCT07194070 shows while recruiting
NCT07194070 is an observational study that tracks outcomes without assigning an intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Hemolytic Disease of the Fetus and Newborn appearing as the primary indexed condition, and to 1 intervention - of which Standard of Care is the first listed.
NCT07194070 lists 10 locations in 5 states (Other, Indiana, Ohio).
Frequently Asked Questions
What is clinical trial NCT07194070 about?
NCT07194070 is a clinical study titled "A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry". The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving st...
What is the current status of trial NCT07194070?
This trial is currently recruiting. The enrollment target is 175 participants. The study started on 2025-02-20. Estimated completion is 2030-09-30.
What conditions does trial NCT07194070 study?
This clinical trial studies the following conditions: Hemolytic Disease of the Fetus and Newborn.
What interventions are being tested in trial NCT07194070?
The interventions under investigation include: Standard of Care (OTHER).
Who is sponsoring clinical trial NCT07194070?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07194070 being conducted?
This trial has 10 study locations across Indiana, Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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