Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT06141733
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2023-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
2 Year Follow up of COSGOD III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Death', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Mortality mentioned in Patients charts'}, {'measure': 'Conditions of neurodevelopmental outcome - Bailey Scores', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Testing or information from Patients charts Bailey Scores'}, {'measure': 'Conditions of neurodevelopmental outcome- PARCA-R Score', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Testing or information from Patients charts PARCA-R Scores'}, {'measure': 'Conditions of neurodevelopmental outcome - GMFC Scores', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Testing or information from Patients charts GMFC Scores'}, {'measure': 'Weight', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}, {'measure': 'Length', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}, {'measure': 'Head circumference', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}, {'measure': 'Long term medications', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}, {'measure': 'Presence of chronic diseases', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}, {'measure': 'Sex', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}, {'measure': 'Gestational age', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'Documented in Patients charts'}], 'primaryOutcomes': [{'measure': 'Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age', 'timeFrame': '2 years (18 to 30 months) corrected age', 'description': 'A child will be classified with moderate-or-severe NDD, if any of the four following conditions are present:\n\nCognitive or language disability Bayley II test cognitive scale cut-off will be \\< 85 Bayley III/IV test, cognitive or language composite scale cut-off will be \\< 85 PARCA R non-verbal cognition or language score cut-off will be \\< 70\n\nIf no standardized developmental assessment is available, informal assessment is possible:\n\nless than 5 words\n\nCerebral palsy Gross Motor Function Classification Score (GMFCS) ≥ 2\n\nIf no GMFCS is available, informal assessment is possible:\n\nNot able to walk alone\n\nVisual impairment:\n\nImpairment even with glasses or only being able to perceive light or being blind (one or two eyes)\n\nHearing impairment Impairment defined as hearing loss corrected with aids or being deaf'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodevelopmental Disability', 'Death']}, 'referencesModule': {'references': [{'pmid': '36693654', 'type': 'BACKGROUND', 'citation': 'Pichler G, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law B, Urlesberger B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Schwaberger B, Klebermass-Schrehof K, Schmolzer GM; COSGOD III study group. Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial. BMJ. 2023 Jan 24;380:e072313. doi: 10.1136/bmj-2022-072313.'}]}, 'descriptionModule': {'briefSummary': "The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available.\n\nHowever, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire.\n\nAim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Months', 'minimumAge': '18 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm neonates included in COSGOD III trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)\n\nExclusion Criteria:\n\n* \\< 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)'}, 'identificationModule': {'nctId': 'NCT06141733', 'acronym': 'COSGODIII-FU', 'briefTitle': '2 Year Follow up of COSGOD III', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': '2 Year Follow up of COSGOD III (COSGOD III-FU)- Ancillary Retrospective Observational Study to COSGOD III Trial', 'orgStudyIdInfo': {'id': '36-041 ex 23/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NIRS (Near-infrared spectroscopy) group of the COSGOD III trial', 'description': 'A multi-center, multi-national randomized-controlled trial was performed in 11 centers in Europe and Canada. Preterm neonates less than 32 weeks gestation were randomly assigned to standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.\n\nIn the NIRS-group 252 (82.9%) out of 303 neonates (gestational-age, median (interquartile-range): 28.9 (26.9-30.6) weeks) survived without cerebral injury until term age or discharge. (primary outcome of the COSGOD III trial)', 'interventionNames': ['Other: NIRS group']}, {'label': 'Control group of the COSGOD III trial', 'description': 'A multi-center, multi-national randomized-controlled trial was performed in 11 centers in Europe and Canada. Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) during immediate transition (first 15 minutes after birth) and resuscitation.\n\nIn the Control-group 238 (78.5%) out of 304 neonates (gestational-age, median (interquartile-range): 28.6 (26.6-30.6) weeks) survived without cerebral injury until term age or discharge. (primary outcome of the COSGOD III trial)'}], 'interventions': [{'name': 'NIRS group', 'type': 'OTHER', 'description': 'Standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.', 'armGroupLabels': ['NIRS (Near-infrared spectroscopy) group of the COSGOD III trial']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Edmonton', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Centre for Ped. Clinical Studies Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'University College Cork', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale dei Bambini "V.Buzzi" Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Institute for Maternal and Child Health, IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Ginekologiczno Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Gerhard Pichler, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': "Vittore Buzzi Children's Hospital", 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'University College Cork', 'class': 'OTHER'}, {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}