Intelligence Changes Following Minor Surgery
This study is currently recruiting participants.
Verified March 2012 by RenJi Hospital
Sponsor:
RenJi Hospital
Collaborator:
Shanghai Children's Medical Center
Information provided by (Responsible Party):
diansan su, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01483313
First received: October 13, 2011
Last updated: March 7, 2012
Last verified: March 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 13, 2011 | ||||
| Last Updated Date | March 7, 2012 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Wechsler Intelligence Scale for Children [ Time Frame: Average 5 years after surgery ] [ Designated as safety issue: No ] Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01483313 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Achenbach Child Behavior Checklist [ Time Frame: Average 5 years after surgery ] [ Designated as safety issue: No ] Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intelligence Changes Following Minor Surgery | ||||
| Official Title ICMJE | Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery | ||||
| Brief Summary | Animal studies showed that many general anesthetics might result in neuron apoptosis and neurocognitive impairment in the developing brain. However results from human studies are conflicted. In present study, the investigators examined the association between early exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence using the Wechsler Intelligence Scale for Children. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The investigators would like chose the Children who undergone minor surgery in Renji hospital 4-6years ago and their friends who never had any surgery. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 800 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 6 Years to 16 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01483313 | ||||
| Other Study ID Numbers ICMJE | RenJiH-20111005 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | diansan su, RenJi Hospital | ||||
| Study Sponsor ICMJE | RenJi Hospital | ||||
| Collaborators ICMJE | Shanghai Children's Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | RenJi Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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