Normal blood clotting values in premature infants
Normal Hemostasis Values in Premature Infants
We will look at past lab tests to see what normal blood clotting values are from birth until 18 months in babies born before 37 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 0 Months to 18 Months |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07349251 on ClinicalTrials.gov |
What this trial studies
This retrospective observational study compiles hemostasis test results from infants born before 37 weeks whose samples were sent to the Hematology Laboratory at Strasbourg University Hospital. Selected coagulation parameters will be collected from birth through 18 months and analyzed by age to define expected ranges. Infants with incomplete data, congenital bleeding disorders, coagulopathy, or hepatocellular insufficiency will be excluded. Results will be compared where possible with reference values from full-term infants to identify differences.
Who should consider this trial
Good fit: Ideal candidates are infants born before 37 weeks and aged 18 months or younger whose hemostasis samples were sent to the CHU Strasbourg Hematology Laboratory and who do not have known congenital bleeding disorders or liver failure.
Not a fit: Infants with known congenital hemostasis disorders, existing coagulopathy, hepatocellular insufficiency, or incomplete laboratory records are unlikely to benefit from this reference-range project.
Why it matters
Potential benefit: If successful, the results could give clinicians clearer age-specific clotting reference ranges for preterm infants and help avoid misdiagnosis or unnecessary treatment.
How similar studies have performed: Previous research has described neonatal coagulation patterns, but large retrospective cohorts specifically defining age-related hemostasis ranges in preterm infants through 18 months are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Strasbourg
- Laboratoire d'Hématologie - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Agathe HERB, PharmD
- Email: agathe.herb@chru-strasbourg.fr
- Phone: 33 3 88 12 75 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.