Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-06 @ 3:02 AM
Study NCT ID:
NCT03002792
Status:
UNKNOWN
Last Update Posted:
2017-11-28
First Post:
2016-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, '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': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-26', 'studyFirstSubmitDate': '2016-12-17', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Full Scale Intelligence Quotient (IQ)', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)'}], 'secondaryOutcomes': [{'measure': 'Verbal Comprehension Index', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to WPPSI-IV'}, {'measure': 'Visual Spatial Index', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to WPPSI-IV'}, {'measure': 'Fluid Spatial Index', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to WPPSI-IV'}, {'measure': 'Working Memory Index', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to WPPSI-IV'}, {'measure': 'Processing Speed Index', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to WPPSI-IV'}, {'measure': 'Executive Function', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)'}, {'measure': 'Adaptive Behavior', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to Adaptive Behavior Assessment System second edition'}, {'measure': 'Emotion Comprehension', 'timeFrame': '24-28 weeks after enrollment', 'description': 'according to Test of Emotion Comprehension(TEC) (designed by Pons \\& Harris ,2000)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anesthesia', 'neurodevelopment', 'dental caries'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '21708249', 'type': 'BACKGROUND', 'citation': 'Zou X, Liu F, Zhang X, Patterson TA, Callicott R, Liu S, Hanig JP, Paule MG, Slikker W Jr, Wang C. Inhalation anesthetic-induced neuronal damage in the developing rhesus monkey. Neurotoxicol Teratol. 2011 Sep-Oct;33(5):592-7. doi: 10.1016/j.ntt.2011.06.003. Epub 2011 Jun 25.'}, {'pmid': '21241795', 'type': 'BACKGROUND', 'citation': 'Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):220-30. doi: 10.1016/j.ntt.2011.01.001. Epub 2011 Jan 15.'}, {'pmid': '23994303', 'type': 'BACKGROUND', 'citation': 'Shen X, Liu Y, Xu S, Zhao Q, Guo X, Shen R, Wang F. Early life exposure to sevoflurane impairs adulthood spatial memory in the rat. Neurotoxicology. 2013 Dec;39:45-56. doi: 10.1016/j.neuro.2013.08.007. Epub 2013 Aug 27.'}, {'pmid': '21368654', 'type': 'BACKGROUND', 'citation': 'Hansen TG, Pedersen JK, Henneberg SW, Pedersen DA, Murray JC, Morton NS, Christensen K. Academic performance in adolescence after inguinal hernia repair in infancy: a nationwide cohort study. Anesthesiology. 2011 May;114(5):1076-85. doi: 10.1097/ALN.0b013e31820e77a0.'}, {'pmid': '22908104', 'type': 'BACKGROUND', 'citation': 'Ing C, DiMaggio C, Whitehouse A, Hegarty MK, Brady J, von Ungern-Sternberg BS, Davidson A, Wood AJ, Li G, Sun LS. Long-term differences in language and cognitive function after childhood exposure to anesthesia. Pediatrics. 2012 Sep;130(3):e476-85. doi: 10.1542/peds.2011-3822. Epub 2012 Aug 20.'}, {'pmid': '19293700', 'type': 'BACKGROUND', 'citation': 'Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.'}, {'pmid': '27655179', 'type': 'BACKGROUND', 'citation': 'Graham MR, Brownell M, Chateau DG, Dragan RD, Burchill C, Fransoo RR. Neurodevelopmental Assessment in Kindergarten in Children Exposed to General Anesthesia before the Age of 4 Years: A Retrospective Matched Cohort Study. Anesthesiology. 2016 Oct;125(4):667-677. doi: 10.1097/ALN.0000000000001245.'}, {'pmid': '27272582', 'type': 'BACKGROUND', 'citation': 'Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.'}, {'pmid': '26507180', 'type': 'BACKGROUND', 'citation': 'Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether early expose to general anaesthesia will influence neurodevelopment.', 'detailedDescription': 'Participants, according to the state of illness and clinical requirements, assigned to receive dental caries treatment with or without general anesthesia. During the follow-up, various of neurodevelopment assessment will be done at specific timepoint to investigate whether general anaesthesia will influence neurodevelopment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients revieve carves treatment in Department of Pediatric Dentistry，School of Stomatology, the Fourth Military Medical University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age\\>=36 weeks\n* American Society of Anesthesiologists（ASA） physical status Ⅰ or Ⅱ，with very limited systemic disease.\n* Age\\<=6 yr\n\nExclusion Criteria:\n\n* did not provide research authorization；\n* unable to contact or inconvenient for follow-up;\n* hypersensitive to general anesthesia drug;\n* previous exposure to general anesthesia in utero;\n* previous exposure to general anesthesia as a neonate\n* previous exposure to psychotropic medication;\n* complications at birth such as low weigh, hypoxia, or cerebral edema;\n* any other known diseases may influence the neurodevelopment'}, 'identificationModule': {'nctId': 'NCT03002792', 'briefTitle': 'Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia', 'orgStudyIdInfo': {'id': '2014KTCL03_05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'general anesthesia', 'description': 'caries treatment under general anesthesia', 'interventionNames': ['Procedure: general anesthesia']}, {'label': 'caries treatment only', 'description': 'caries treatment without general anesthesia'}], 'interventions': [{'name': 'general anesthesia', 'type': 'PROCEDURE', 'description': 'nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane', 'armGroupLabels': ['general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Xin Qi, Postgraduate', 'role': 'CONTACT', 'email': 'qixin-166@163.com', 'phone': '(+86)029-84776230'}, {'name': 'Bing Liu, Master', 'role': 'CONTACT', 'email': 'adalb729@163.com', 'phone': '(+86)029-84776230'}, {'name': 'Hui Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guoliang Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rui Lu, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lirong Liang, Postgraduate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'School of Stomatology, the Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Hui Zhang, M.D.', 'role': 'CONTACT', 'email': 'zhanghuifmmua@163.com', 'phone': '(+86)029-84776119'}], 'overallOfficials': [{'name': 'Hui Zhang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Stomatology, the Fourth Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D. Director and Professor, Department of Anaesthesiology, School of Stomatology', 'investigatorFullName': 'Hui Zhang', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}