Status:
COMPLETED
PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Office of Acquisitions and Grants Services (OAGS)
Conditions:
Cognition - Other
Eligibility:
All Genders
8-15 years
Brief Summary
The purpose of this study is to determine whether the use of anesthetic agents in infants and children have long term adverse effects on neurocognitive development. According to the National Hospital ...
Detailed Description
The purpose of our study is to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during surgery before 36 months of age (exposed sibling cohorts) and who would ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Exposed cohort:
- Subjects who had inguinal hernia surgery before 36 months of age
- Ages 8 yr, 0 mo to 15 yr, 0 mo
- Gestation age greater or equal to 36 weeks
- Categorized as ASA I or ASA II
- English speaking
- Biologically related to the unexposed sibling
- Unexposed cohort:
- Sibling within 36 months of age of the exposed cohort
- Never had surgery or exposure to anesthesia prior to 36 months of age
- Ages 8 yr, 0 mo to 15 yr, 0 mo
- Gestation age greater or equal to 36 weeks
- Categorized as ASA I or ASA II
- 5\. English speaking 6. Biologically related to the exposed sibling
- Exclusion criteria:
- Exposed cohort:
- Gestational age less than 36 weeks at birth
- No exposure to surgery or anesthesia prior to 36 months of age
- Surgery/Anesthesia other than index hernia repair prior to 36 months of age
- Not categorized as ASA I or ASA II
- Not ages 8 yr, 0 mo to 15 yr, 0 mo
- Not English speaking
- Not biologically related to the unexposed sibling
- Unexposed cohort:
- Gestational age under 36 weeks at birth
- Any exposure to surgery or anesthesia prior to 36 months of age
- Not categorized as ASA I or ASA II
- Not ages 8 yr, 0 mo to 15 yr, 0 mo
- Not English speaking
- Not biologically related to the unexposed sibling
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00881764
Start Date
May 1 2009
End Date
January 1 2016
Last Update
February 17 2023
Active Locations (4)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Columbia University, 622 W. 168th St.
New York, New York, United States, 10032
3
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232