Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 9:26 AM
Study NCT ID:
NCT06315933
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'full-scale intelligence quotient, FSIQ', 'timeFrame': 'At the time of collecting baseline demographic data', 'description': 'Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)'}], 'secondaryOutcomes': [{'measure': 'Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)', 'timeFrame': 'At the time of collecting baseline demographic data', 'description': 'Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)'}, {'measure': 'CBCL Total score, CBCL Internalizing score, CBCL Externalizing score', 'timeFrame': 'Within six months of WISC-IV assessment', 'description': 'Measured by Child Behavior Checklist (CBCL)'}, {'measure': 'SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score', 'timeFrame': 'Within six months of WISC-IV assessment', 'description': 'Measured by Strengths and Difficulties Questionnaire (SDQ)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anesthetics Toxicity']}, 'referencesModule': {'references': [{'pmid': '23460572', 'type': 'BACKGROUND', 'citation': 'Istaphanous GK, Ward CG, Nan X, Hughes EA, McCann JC, McAuliffe JJ, Danzer SC, Loepke AW. Characterization and quantification of isoflurane-induced developmental apoptotic cell death in mouse cerebral cortex. Anesth Analg. 2013 Apr;116(4):845-54. doi: 10.1213/ANE.0b013e318281e988. Epub 2013 Mar 4.'}, {'pmid': '23109147', 'type': 'BACKGROUND', 'citation': 'Brambrink AM, Back SA, Riddle A, Gong X, Moravec MD, Dissen GA, Creeley CE, Dikranian KT, Olney JW. Isoflurane-induced apoptosis of oligodendrocytes in the neonatal primate brain. Ann Neurol. 2012 Oct;72(4):525-35. doi: 10.1002/ana.23652.'}, {'pmid': '20124985', 'type': 'BACKGROUND', 'citation': 'Briner A, De Roo M, Dayer A, Muller D, Habre W, Vutskits L. Volatile anesthetics rapidly increase dendritic spine density in the rat medial prefrontal cortex during synaptogenesis. Anesthesiology. 2010 Mar;112(3):546-56. doi: 10.1097/ALN.0b013e3181cd7942.'}, {'pmid': '26002228', 'type': 'BACKGROUND', 'citation': 'Zhang H, Du L, Du Z, Jiang H, Han D, Li Q. Association between childhood exposure to single general anesthesia and neurodevelopment: a systematic review and meta-analysis of cohort study. J Anesth. 2015 Oct;29(5):749-57. doi: 10.1007/s00540-015-2030-z. Epub 2015 May 23.'}, {'pmid': '30782342', 'type': 'BACKGROUND', 'citation': 'McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.'}, {'pmid': '30982593', 'type': 'BACKGROUND', 'citation': 'Zaccariello MJ, Frank RD, Lee M, Kirsch AC, Schroeder DR, Hanson AC, Schulte PJ, Wilder RT, Sprung J, Katusic SK, Flick RP, Warner DO. Patterns of neuropsychological changes after general anaesthesia in young children: secondary analysis of the Mayo Anesthesia Safety in Kids study. Br J Anaesth. 2019 May;122(5):671-681. doi: 10.1016/j.bja.2019.01.022.'}, {'pmid': '30348358', 'type': 'BACKGROUND', 'citation': 'Baky FJ, Milbrandt TA, Flick R, Larson AN. Cumulative Anesthesia Exposure in Patients Treated for Early-Onset Scoliosis. Spine Deform. 2018 Nov-Dec;6(6):781-786. doi: 10.1016/j.jspd.2018.05.001.'}, {'pmid': '35924646', 'type': 'BACKGROUND', 'citation': 'Ruiz G, Torres-Lugo NJ, Marrero-Ortiz P, Guzman H, Olivella G, Ramirez N. Early-onset scoliosis: a narrative review. EFORT Open Rev. 2022 Aug 4;7(8):599-610. doi: 10.1530/EOR-22-0040.'}, {'pmid': '29258430', 'type': 'BACKGROUND', 'citation': 'Zhang Q, Peng Y, Wang Y. Long-duration general anesthesia influences the intelligence of school age children. BMC Anesthesiol. 2017 Dec 19;17(1):170. doi: 10.1186/s12871-017-0462-8.'}, {'pmid': '30703588', 'type': 'BACKGROUND', 'citation': 'Lin T, Meng Y, Ji Z, Jiang H, Shao W, Gao R, Zhou X. Extent of Depression in Juvenile and Adolescent Patients with Idiopathic Scoliosis During Treatment with Braces. World Neurosurg. 2019 Jun;126:e27-e32. doi: 10.1016/j.wneu.2019.01.095. Epub 2019 Jan 29.'}, {'pmid': '41338617', 'type': 'DERIVED', 'citation': 'Dai Z, Zhang Y, Ma L, Zhang J, Huang Y. Association between general anaesthesia exposure and neurodevelopment in children with congenital scoliosis at a Chinese tertiary hospital: study protocol for a prospective longitudinal observational cohort study. BMJ Open. 2025 Dec 2;15(12):e108845. doi: 10.1136/bmjopen-2025-108845.'}]}, 'descriptionModule': {'briefSummary': 'In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children diagnosed with congenital scoliosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with congenital scoliosis\n* 6-16 years old at the time of assessment\n\nExclusion Criteria:\n\n* Cognitive impairment caused by congenital, traumatic or other reasons;\n* Existence of mental or psychological disorders;\n* There are factors that may affect neurological development, including any known central nervous system disease, neurological injury, or history of neonatal asphyxia;\n* Unable to cooperate with cognitive function tests;\n* The child is unable to communicate in Chinese.'}, 'identificationModule': {'nctId': 'NCT06315933', 'briefTitle': 'Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Long-term Effect of General Anesthesia Before School Age on Neurodevelopment in Children With Congenital Scoliosis', 'orgStudyIdInfo': {'id': 'S-K1093'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unexposed', 'description': 'Children unexposed to general anesthesia before school age (\\<=6y)'}, {'label': 'Singly exposed', 'description': 'Children singly exposed to general anesthesia before school age (\\<=6y)', 'interventionNames': ['Procedure: General anesthesia']}, {'label': 'Multiply exposed', 'description': 'Children multiply exposed to general anesthesia before school age (\\<=6y)', 'interventionNames': ['Procedure: General anesthesia']}], 'interventions': [{'name': 'General anesthesia', 'type': 'PROCEDURE', 'description': 'General anesthesia including inhaled and intravenous', 'armGroupLabels': ['Multiply exposed', 'Singly exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lulu Ma, Dr.', 'role': 'CONTACT', 'email': 'malulu@pumch.cn', 'phone': '0086-010-13811049619'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lulu Ma, Dr.', 'role': 'CONTACT', 'email': 'malulu@pumch.cn', 'phone': '0086-10-13811049619'}, {'name': 'Ziyi Dai, Dr.', 'role': 'CONTACT', 'email': 'daiziyi@pumch.cn', 'phone': '0086-10-18611703606'}], 'overallOfficials': [{'name': 'Lulu Ma, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'starting 1 year after the results are published', 'ipdSharing': 'YES', 'description': 'IPD that underlie results in a publication', 'accessCriteria': 'IPD is available on appropriate request from the Principle Investigator by email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician, Professor', 'investigatorFullName': 'Lulu Ma', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}