Normal Hemostasis Values in Premature Infants | NCT07349251

Studies
Normal Hemostasis Values in Premature Infants

NCT07349251

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Premature Infant, Hemostasis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2025Actual

Primary Completion Date

Nov 2031Estimated

Completion Date

Nov 24, 2031Estimated

First Submitted Date

Jan 8, 2026

First Submission Date that Met QC Criteria

Jan 8, 2026

First Posted Date

Jan 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

18 Months

Standard Ages

Child

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agathe HERB, PharmD	Contact	33 3 88 12 75 53		agathe.herb@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratoire d'Hématologie - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided