Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT07198360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Intraventricular Hemorrhage in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-09-14', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '. To determine the incidence of IVH in preterm infants within the first 7 days of life using cranial ultrasound. . To assess the grade of IVH (Papile classification I-IV) in preterm infants based on cranial US findings.', 'timeFrame': 'Baseline', 'description': 'Outcome of intraventricular haemorrhage in preterm infants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraventricular Hemorrhage of Prematurity']}, 'referencesModule': {'references': [{'pmid': '32218535', 'type': 'BACKGROUND', 'citation': 'Parodi A, Govaert P, Horsch S, Bravo MC, Ramenghi LA; eurUS.brain group. Cranial ultrasound findings in preterm germinal matrix haemorrhage, sequelae and outcome. Pediatr Res. 2020 Mar;87(Suppl 1):13-24. doi: 10.1038/s41390-020-0780-2.'}, {'pmid': '37609772', 'type': 'BACKGROUND', 'citation': 'Kolnik SE, Upadhyay K, Wood TR, Juul SE, Valentine GC. Reducing Severe Intraventricular Hemorrhage in Preterm Infants With Improved Care Bundle Adherence. Pediatrics. 2023 Sep 1;152(3):e2021056104. doi: 10.1542/peds.2021-056104.'}, {'pmid': '35837759', 'type': 'BACKGROUND', 'citation': 'Legge N, Lutz T, Wocadlo C, Rieger I. Long-term neurodevelopmental outcome in preterm infants with intraventricular haemorrhage. J Paediatr Child Health. 2022 Oct;58(10):1797-1802. doi: 10.1111/jpc.16108. Epub 2022 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'To determine the incidence and grading of IVH among preterm neonates in the NICU.\n\n* To identify maternal and neonatal risk factors associated with IVH.\n* To assess short-term outcomes (mortality, Hydrocephalus, need for neurosurgical intervention, seizures, length of Hospital stay).', 'detailedDescription': 'Intraventricular hemorrhage (IVH) is described as bleeding that occurs within and surrounding the brain ventricles, which contain cerebrospinal fluid . IVH is one of the most severe complications affecting preterm newborns globally, frequently leading to poor prognoses and potential mortality due to both short- and long-term neurodevelopmental consequences. The risk is markedly elevated for preterm newborns with a short gestational age, as roughly 15-20% of those born prior to 32 weeks of gestation are at the greatest risk of suffering a severe form of intraventricular hemorrhage . In term newborns, IVH occurs with an incidence of 5.5%, primarily due to perinatal head trauma, birth hypoxia, or coagulation disorders .\n\nThe IVH is diagnosed using cranial ultrasound (CUS), which is performed within the first 72 hours of life and repeated as clinically indicated. The IVH grade will be classified according to the Papile classification, which includes Grades I, II, III, and IV . Grades I and II were classified as mild intraventricular hemorrhage (IVH), whereas grades III and IV were classified as severe IVH. Grade IV IVH is now designated as periventricular hemorrhage infarction or parenchymal hemorrhage in recent years .\n\nThe risk factors for IVH include acute placental inflammation, elevated leukocyte count within the first 72 hours post-birth, increased white blood cell levels, and male sex. Additional risk factors for IVH encompass prematurity, low birthweight (LBW), prolonged mechanical ventilation, a low 5-minute Apgar score, hypoxia-related injury, hypothermic ischemia, pneumothorax, thrombocytopenia, antenatal maternal hemorrhage, maternal infection or inflammation, sepsis, hypotension, hypoxia, hypercapnia, seizures, patent ductus arteriosus (PDA), infection, respiratory distress, and genetic predispositions .\n\nIVH in neonates, particularly preterm infants, often presents with nonspecific clinical signs such as apnea, bradycardia, hypotonia, bulging fontanelle, seizures, or a sudden drop in hematocrit. Some cases may be clinically silent, making routine screening essential . The diagnosis is primarily made using transcranial ultrasound (cranial sonography), which is a non-invasive, bedside imaging tool capable of detecting IVH grades, ventricular dilation, and parenchymal involvement through the anterior fontanelle. Outcomes vary depending on the severity (graded IIV), with lower grades (III) often resolving without long-term consequences, while higher grades (IIIIV) are associated with complications such as post-hemorrhagic hydrocephalus, cerebral palsy, developmental delay, and increased mortality. Early detection through serial ultrasound monitoring plays a critical role in management and prognosis .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All with the required Criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates \\< 34 weeks of gestation\n* Birth weight \\< 1500g\n* Admitted to NICU within 24 hours of birth\n\nExclusion Criteria:\n\n* Major congenital malformations (especially CNS anomalies)\n* Severe perinatal asphyxia\n* Neonates with congenital infections (TORCH)'}, 'identificationModule': {'nctId': 'NCT07198360', 'briefTitle': 'Outcome of Intraventricular Hemorrhage in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Incidence, Risk Factors, and Outcomes of Intraventricular Hemorrhage in Preterm Infants Admitted to the NICU', 'orgStudyIdInfo': {'id': 'IVH in preterm infants'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Not found'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Romany Nady Isaac Ayad', 'role': 'CONTACT', 'email': 'romanynady2223@gmail.com', 'phone': '01142602768'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric resident', 'investigatorFullName': 'Romany Nady Isaac Ayad', 'investigatorAffiliation': 'Assiut University'}}}}