Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-27 @ 7:10 AM
Study NCT ID:
NCT06731205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Renal Prognosis of Neonatal Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1852}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-29', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic kidney disease (CKD)', 'timeFrame': '1-3 years', 'description': 'The incidence of CKD stage 3-5 (eGFR \\< 60 ml/min) within 1, 2, and 3 years of follow-up'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1-3 years'}, {'measure': 'Incidence of renal replacement therapy', 'timeFrame': '1-3 years'}, {'measure': 'Incidence of proteinuria', 'timeFrame': '1-3 years'}, {'measure': 'Incidence of height retardation', 'timeFrame': '1-3 years'}, {'measure': 'Incidence of hypertension', 'timeFrame': '1-3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal Acute Kidney Injury', 'Long-Term Prognosis', 'Prognosis and Predictive Factors', 'Biomarkers'], 'conditions': ['Neonatal Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to conduct a multicenter, prospective neonatal acute kidney injury (AKI) follow-up cohort to describe the clinical characteristics of chronic kidney disease (CKD) in AKI cases within 1 year of follow-up and screen for effective biomarkers that can early warn of CKD progression. Ultimately, a neonatal AKI adverse prognosis warning model based on multidimensional data will be established to provide new data and new models for CKD management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who gave birth, were admitted to NICU and were diagnosed with neonatal AKI from Jan 2025 to Dec 2025 at the Women and Children's Medical Center of Guangzhou Medical University and other hospitals participating in this project.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Delivered in this hospital and subsequently admitted to the NICU during the study period;\n* Diagnosed with neonatal AKI according to the 2015 KDIGO neonatal AKI criteria;\n* Age \\<28 days.\n\nExclusion Criteria:\n\n* Severe hydronephrosis diagnosed by prenatal renal ultrasound;\n* Patients with congenital urinary malformations, including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal dysplasia, and obstructive uropathy;\n* Newborns who required congenital heart surgery within the first 7 days after birth;\n* Newborns whose mothers had a history of renal failure;\n* Death within 48 hours after birth;\n* Other genetic syndromes or medical conditions were not eligible for inclusion according to the attending neonatologist's judgment."}, 'identificationModule': {'nctId': 'NCT06731205', 'briefTitle': 'Long-term Renal Prognosis of Neonatal Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Long-term Renal Prognosis of Neonatal Acute Kidney Injury: A Multicenter, Prospective Cohort Study', 'orgStudyIdInfo': {'id': '[2024]442A01'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xia Gao', 'role': 'CONTACT', 'email': 'gaoxiagz@vip.163.com', 'phone': '86-020-38370569'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}