NCT00881764

PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study

Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 369 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

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 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.

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 be from ages 8yr, 0 mo to15 yr, 0 mo at the time of the study; and the other who never had anesthesia or surgery less than 36 months of age, is from ages 8yr, 0mo to 15 yr, 0 mo at the time of the study, and is within 36 months of age range from the exposed sibling(unexposed sibling cohort). Neuropsychological assessments are administered to the sibling cohorts prospectively and parents of the siblings will complete parental interviews/questionnaires. We assess individually neurocognitive, behavioral and emotional function for both exposed and unexposed siblings. Family function will also be evaluated. We will also obtain complete medical history for each participant, including significant perinatal events and social history. We also review medical records when appropriate. All testing are performed during a one day site visit.

Conditions

• Cognition - Other

Interventions

Type	Name	Description
PROCEDURE	Inguinal hernia surgery	Non-experimental procedure
PROCEDURE	General anesthesia	Non-experimental procedure/treatment

Timeline

• Start date: 2009-05-01
• Primary completion: 2015-04-01
• Completion: 2016-01-01
• First posted: 2009-04-15
• Last updated: 2023-02-17

Locations

4 sites across 1 country: United States