PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
Completed
Conditions studied: Cognition - Other
In brief
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 Discharge Survey, around 2.5 million children have surgical procedures requiring anesthesia each year in the US. Recent animal studies have suggested that the exposure of the immature organism to a variety of commonly used anesthetic agents may lead to neurobehavioral functional deficits in vivo and to neuronal apoptosis in vitro. While the relevance of these findings on children exposed to anesthetics remains to be determined, it is clearly critically important to public health that this issue is resolved quickly and clearly. Hypothesis: Exposure to anesthetic agents within the first three years of life will not significantly impair cognitive functions at ages 8 yr, 0 mo to 15 yr, 0 mo.
Key facts
- Study ID
- NCT00881764
- Run by
- Columbia University
- People needed
- 369
- Starts
- 2009-05-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2023-02-17
Who can join
Age: 8 and older, up to 15. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- English speaking 6. Biologically related to the exposed sibling
You may not qualify if…
- 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
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
- Columbia University, 622 W. 168th St. — New York, New York, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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