CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 369 enrolled
Drug / intervention
Inguinal hernia surgery +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00881764
NCT00881764N/ACompleted

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

Columbia University·observational·Posted Apr 15, 2009·Updated Feb 17, 2023

In Brief

An observational study evaluating Inguinal hernia surgery and General anesthesia for Cognition - Other. Completed, enrolled 369 participants across 4 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2009
Enrollment StartMay 1, 2009
Primary CompletionApr 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 17.2 years ago

Interventions

Inguinal hernia surgeryprocedure

Non-experimental procedure

General anesthesiaprocedure

Non-experimental procedure/treatment