Feasibility Study for PANDAS
| Tracking Information | |||||
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| First Received Date ICMJE | September 16, 2008 | ||||
| Last Updated Date | September 14, 2009 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary endpoint of this feasibility study is to determine if there is an adequate population of sibling pairs at CHOP to warrant participation in a future PANDAS study. [ Time Frame: 6-9 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00754897 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Feasibility Study for PANDAS | ||||
| Official Title ICMJE | Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS) | ||||
| Brief Summary | We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during inguinal hernia surgery before three years of age (exposed) and the other who was not exposed to anesthesia or surgery in the first three years of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility study to determine if there is an adequate number of subjects for each of the two age groups before the formal study begins. |
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| Detailed Description | Feasibility study to obtain information through a telephone interview with parents of eligible children Once we identify the children who were less than one year of age and those between the ages of 1 and 3 that who had inguinal hernia surgery during the years of 1999-2007, we will call the parents to determine if the index patients have siblings. If so, we would also ask if there is a sibling within 3 years of the index patient's age and if they have had no exposure to anesthetics or sedatives before their third birthday. Exclusion criteria for both index patients and siblings would include gestational age at birth of < 36 weeks, any history of hospitalization, including neonatal ICU, a history of CNS, cardiac, or pulmonary diseases requiring medical treatment, or a history of subsequent surgery or exposure of anesthetics or sedatives. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not had any exposure to anesthetics agents or sedatives before their 3rd birthday. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
We will do a database search to identify children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not have any exposure to anesthetics agents or sedatives before their 3rd birthday. |
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| 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 | Completed | ||||
| Enrollment ICMJE | 72 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 3 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00754897 | ||||
| Other Study ID Numbers ICMJE | 2008-06-7001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ronald Litman, DO, The Children's Hospital of Philadelphia | ||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
| Collaborators ICMJE | Children's Anesthesiology Associates, Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||
| Verification Date | September 2009 | ||||
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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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