Inguinal Hernia Clinical Trial
Official title:
Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 3 Years |
Eligibility |
Inclusion Criteria: 1. Males or females age 0 to 1 year. 2. Inguinal hernia surgery between 1/1/1999 and 12/31/2007. 3. Parental/guardian permission (informed consent). Exclusion Criteria: 1. Gestational age < 36 weeks. 2. Any history of hospitalization, including neonatal ICU. 3. A history of CNS, cardiac, or pulmonary diseases requiring medical treatment. 4. History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age. |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Children's Anesthesiology Associates, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6-9 months | No |
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