Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT07157020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years.', 'timeFrame': 'The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively.', 'description': 'NDI can be diagnosed if any of the following conditions are met.\n\n* Cerebral palsy;\n\n * Griffiths score \\<85 points for the corresponding age: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively. Any assessment score lower than 85 points is considered a positive event.\n\n * Sensorineural or mixed hearing impairment and non-congenital hearing loss require hearing AIDS or cochlear implants\n\n ④ Bilateral visual impairment;\n * Epilepsy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraventricular Hemorrhage of Prematurity', 'prevention', 'early detection', 'clinical evaluation'], 'conditions': ['Intraventricular Hemorrhage of Prematurity']}, 'descriptionModule': {'briefSummary': '1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a scientific basis for optimizing clinical intervention.\n2. Apply ultrasound radiomics technology to explore and formulate new standards for imaging diagnosis and treatment; By integrating metabolomics, ultrasound radiomics and clinical data, high-risk individuals for intracranial hemorrhage and their relationship with prognosis can be identified early.\n3. To explore whether advancing the indication for surgical intervention of hydrocephalus in preterm infants after hemorrhage from ventricular index P97+4mm to P97 and whether repeated lumbar puncture and drainage can improve their prognosis, with the aim of clarifying the optimal timing for intervention of hydrocephalus in preterm infants after hemorrhage and optimizing the treatment methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age: 23+0 weeks to 36+6 weeks;\n* Post-hemorrhagic hydrocephalus is confirmed by cranial ultrasound or other cranial imaging examinations.\n* No cerebrospinal fluid drainage treatment was received before enrollment.\n\nExclusion Criteria:\n\n* Excluding secondary IVH, including but not limited to congenital malformations, vitamin K1 deficiency, abnormal coagulation function, etc.\n* Excluding hydrocephalus caused by other reasons, including but not limited to infection, congenital malformations, intracranial space-occupying lesions, etc.\n* Treatment before diagnosis of hydrocephalus after intraventricular hemorrhage or suspected presence of central nervous system infection.'}, 'identificationModule': {'nctId': 'NCT07157020', 'acronym': 'ROPEDACEOIHIPI', 'briefTitle': 'Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2025-06-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-threshold intervention group', 'description': 'VI\\>P97，but ≤ P97+4mm', 'interventionNames': ['Procedure: ommaya capsule implantation technique']}, {'type': 'EXPERIMENTAL', 'label': 'high-threshold intervention group', 'description': 'VI\\>P97+4mm', 'interventionNames': ['Procedure: ommaya capsule implantation technique']}], 'interventions': [{'name': 'ommaya capsule implantation technique', 'type': 'PROCEDURE', 'otherNames': ['Lumbar puncture drainage'], 'description': 'Intervention criteria: Low-threshold intervention group and high--threshold intervention group', 'armGroupLabels': ['Low-threshold intervention group', 'high-threshold intervention group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}