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A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
NCT07194070 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07194070
The ClinicalTrials.gov registry entry for NCT07194070 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07194070 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Other, Indiana, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07194070?
The interventions under investigation include: Standard of Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07194070?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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