Normal Hemostasis Values in Premature Infants (PRHEMO)

January 8, 2026 updated by: University Hospital, Strasbourg, France
This study aims to retrospectively determine, in a large cohort of apparently healthy children born before 37 weeks of gestation, the expected values of certain hemostasis parameters from birth to 18 months (when they start walking), and to determine whether or not they differ from those of full-term infants.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Laboratoire d'Hématologie - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Agathe HERB, PharmD
        • Sub-Investigator:
          • Laurent Sattler, MD
        • Principal Investigator:
          • David Millard, MD
        • Sub-Investigator:
          • Jordan Wimmer, MD
        • Sub-Investigator:
          • Claire Bopp, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 months or younger for whom a sample was sent to the Hematology Laboratory at Strasbourg University Hospital for measurement of a hemostasis parameter

Description

Inclusion Criteria:

  • Patients aged 18 months or younger for whom a sample was sent to the Hematology Laboratory at Strasbourg University Hospital for measurement of a hemostasis parameter

Exclusion Criteria:

  • Patients with incomplete data
  • Patients with a congenital hemostasis disorder (hemophilia A or B, von Willebrand disease), a coagulopathy, or hepatocellular insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normal hemostasis values in premature infants
Time Frame: Up to 6 years
Normal hemostasis values in premature infants will be determined according to the gestational age at birth
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

November 1, 2031

Study Completion (Estimated)

November 24, 2031

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9948 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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