Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT06105333
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fidgety Movements of Preterm Neonates Included in COSGOD III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-10-06', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term outcome', 'timeFrame': 'Between six to 20 weeks post term in surviving preterm neonates', 'description': 'Combined outcome of survival with normal Fidgety movement analysis. Outcome defined as good (survival with normal fidgety movements) or poor (death, abnormal/absent of fidgety movements). Mortality is assessed by medical documentation system.\n\nFidgety movement assessements were performed by video recording of sequences of at least three minutes. Fidgety movements were documented by clinical staff trained and certified for GMA. FMs were as either normal or abnormal, whereby abnormal FMs are further divided into two categories: absent or abnormal.'}], 'secondaryOutcomes': [{'measure': 'Interventions during resuscitation', 'timeFrame': 'First 15 minutes after birth', 'description': 'Interventions during the first 15 minutes after birth include n (%) of supplemental oxygen, respiratory support, chest compression, caffeine, adrenaline, surfactant, volume. These data were documented in the eCRF.'}, {'measure': 'Interventions during the first 24 hours after birth', 'timeFrame': 'First 24 hours after birth', 'description': 'Interventions during the first 24 hours after birth include n (%) of surfactant, no respiratory support, non-invasive ventilation and mechanical ventilation. These data were documented in the eCRF.'}, {'measure': 'Neonatal morbidity at term age', 'timeFrame': 'Between birth and term age', 'description': 'Neonatal morbidities include n (%) of IVH (any grade), cystic PVL, IRDS, culture proven sepsis, NEC, BPD, ROP and PDA with interventions. These data were documented in the eCRF.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['near-infrared spectroscopy', 'preterm neonates', 'preterm birth', 'cerebral injury', 'cerebral oxygenation', 'resuscitation', 'neurological outcome', 'fidgety movements', 'general movements'], 'conditions': ['Preterm', 'General Movements', 'Fidgety Movements', 'Near Infrared Spectroscopy', 'Neurological Outcome']}, 'descriptionModule': {'briefSummary': 'The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain.\n\nTwo centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements).\n\nAim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge.\n\nThe investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm neonates \\< 32 weeks of gestational age included in COSGOD III trial in Graz and Innsbruck are eligible to be included in this ancillary study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates included in the COSGOD III trial\n* Death\n* Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term\n\nExclusion Criteria:\n\n* Neonates without FM analysis between six to 20 weeks post term'}, 'identificationModule': {'nctId': 'NCT06105333', 'acronym': 'Figdety_Ms', 'briefTitle': 'Fidgety Movements of Preterm Neonates Included in COSGOD III', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Fidgety Movements of Preterm Neonates Included in COSGOD III - Ancillary Retrospective Observational Study to COSGOD III Trial', 'orgStudyIdInfo': {'id': 'Figdety Movements - COSGOD III'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NIRS Group', 'description': '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.', 'interventionNames': ['Procedure: standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline']}, {'label': 'Standard Care Group', 'description': 'Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) with routine monitoring during immediate transition (first 15 minutes after birth) and resuscitation.'}], 'interventions': [{'name': 'standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline', 'type': 'PROCEDURE', 'description': 'CrSO2 (Cerebral regional oxygen saturation) monitoring was visible to the clinical team with the same SpO2 target as in the control group. If SpO2 (oxygen saturation) remained between the 10th and 90th centiles and within local limits, and crSO2 was \\<10th centile according to published reference ranges, FiO2 (fraction of inspired oxygen) was increased by 10-20% every 60 seconds or respiratory support was started or increased. If crSO2 remained \\>10th centile for \\>60 seconds or if rSO2 was \\>90th centile,FiO2 was reduced by 10-20% or respiratory support was adjusted accordingly. If there was a history of blood loss or clinical signs of blood loss, intravenous fluids (10 mL/kg) were considered.', 'armGroupLabels': ['NIRS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christina H. Wolfsberger, MD', 'role': 'CONTACT', 'email': 'christina.wolfsberger@medunigraz.at', 'phone': '00436604422218'}, {'name': 'Gerhard Pichler, Prof.', 'role': 'CONTACT', 'email': 'gerhard.pichler@medunigraz.at'}], 'facility': 'Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ursula Kiechl-Kohlendorfer, Prof', 'role': 'CONTACT'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Christina H. Wolfsberger, MD', 'role': 'CONTACT', 'email': 'christina.wolfsberger@medunigraz.at', 'phone': '00436604422218'}, {'name': 'Gerhard Pichler, Prof', 'role': 'CONTACT', 'email': 'gerhard.pichler@medunigraz.at'}], 'overallOfficials': [{'name': 'Gerhard Pichler, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Neonatology, Medical University of Graz, Austria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}