Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 9:33 AM
Study NCT ID:
NCT07349251
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Hemostasis Values in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2031-11-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal hemostasis values in premature infants', 'timeFrame': 'Up to 6 years', 'description': 'Normal hemostasis values in premature infants will be determined according to the gestational age at birth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature Infant', 'Neonatal Prematurity', 'Preterm Infants', 'Hemostasis'], 'conditions': ['Premature Infant, Hemostasis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Patients with incomplete data\n* Patients with a congenital hemostasis disorder (hemophilia A or B, von Willebrand disease), a coagulopathy, or hepatocellular insufficiency'}, 'identificationModule': {'nctId': 'NCT07349251', 'acronym': 'PRHEMO', 'briefTitle': 'Normal Hemostasis Values in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Normal Hemostasis Values in Premature Infants', 'orgStudyIdInfo': {'id': '9948'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agathe HERB, PharmD', 'role': 'CONTACT', 'email': 'agathe.herb@chru-strasbourg.fr', 'phone': '33 3 88 12 75 53'}, {'name': 'Agathe HERB, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Millard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laurent Sattler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jordan Wimmer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claire Bopp, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Laboratoire d'Hématologie - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Agathe HERB, PharmD', 'role': 'CONTACT', 'email': 'agathe.herb@chru-strasbourg.fr', 'phone': '33 3 88 12 75 53'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}