Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-02-02 @ 12:17 AM
Study NCT ID:
NCT05456659
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Replacement Therapy in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of clinical characteristics of patients, survival and technical modalities of dialysis in children undergoing neonatal dialysis at the Strasbourg University Hospital', 'timeFrame': 'Files analysed retrospectively from January 01, 2010 to December 31, 2021 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal', 'Dialysis', 'Extra-renal purification', 'Neonatal resuscitation'], 'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'The circumstances for setting up dialysis in the neonatal period are multiple: congenital anomaly of the kidney and urinary tract (CAKUT), secondary acute renal failure whose etiologies are multiple (sepsis, hypovolemia, respiratory distress syndrome, neonatal asphyxia, Arterial or venous renal thrombosis, nephrotoxic drugs, etc.), metabolic diseases (mainly hyperammonemia and leucinosis) and post-operative management of heart disease: analysis of the characteristics of the patients in our study and comparison with existing epidemiological data in the literature.\n\nThe decision to set up dialysis in a newborn whose recovery of renal function is uncertain or in a context of acute multi-visceral failure is not always obvious and must be discussed carefully. multidisciplinary in connection with neonatologists, resuscitators and nephrologists as well as families with the consideration of the future quality of life of the child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor under 28 days old, having benefited from a renal purification technique in the pediatric intensive care unit of the University Hospital of Strasbourg', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Minor under 28 days old\n* Having benefited from a renal purification technique in the pediatric intensive care unit of the University Hospital of Strasbourg\n* Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes.\n\nExclusion criteria:\n\n\\- Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes."}, 'identificationModule': {'nctId': 'NCT05456659', 'acronym': 'Neo-Renal', 'briefTitle': 'Renal Replacement Therapy in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Renal Replacement Therapy in Neonates : a Retrospective Monocentric Cohort Study', 'orgStudyIdInfo': {'id': '8615'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ariane ZALOSZYC, MD', 'role': 'CONTACT', 'email': 'ariane.zaloszyc@chru-strasbourg.fr', 'phone': '33 3 88 12 77 49'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}, {'name': 'Ariane ZALOSZYC, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manon KRETZ, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Pédiatrie 1 - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Ariane ZALOSZYC, MD', 'role': 'CONTACT', 'email': 'ariane.zaloszyc@chru-strasbourg.fr', 'phone': '33 3 88 12 77 49'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}