Overview

This trial is active, not recruiting.

Condition cognition - other
Treatments inguinal hernia surgery, general anesthesia
Sponsor Columbia University
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date May 2009
End date December 2016
Trial size 369 participants
Trial identifier NCT00881764, AAAC8756, HHSF223200810036C, R34HD060741, SmartTots

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Change in neurocognitive function
time frame: Varies; when the participant is 8-15 years of age

Secondary Outcomes

Measure
Change in behavioral function
time frame: Varies; when the participant is 8-15 years of age

Eligibility Criteria

Male or female participants from 8 years up to 15 years old.

Inclusion Criteria: Exposed cohort: 1. Subjects who had inguinal hernia surgery before 36 months of age 2. Ages 8 yr, 0 mo to 15 yr, 0 mo 3. Gestation age greater or equal to 36 weeks 4. Categorized as ASA I or ASA II 5. English speaking 6. Biologically related to the unexposed sibling Unexposed cohort: 1. Sibling within 36 months of age of the exposed cohort 2. Never had surgery or exposure to anesthesia prior to 36 months of age 3. Ages 8 yr, 0 mo to 15 yr, 0 mo 4. Gestation age greater or equal to 36 weeks 5. Categorized as ASA I or ASA II 5. English speaking 6. Biologically related to the exposed sibling Exclusion criteria: Exposed cohort: 1. Gestational age less than 36 weeks at birth 2. No exposure to surgery or anesthesia prior to 36 months of age 3. Surgery/Anesthesia other than index hernia repair prior to 36 months of age 4. Not categorized as ASA I or ASA II 5. Not ages 8 yr, 0 mo to 15 yr, 0 mo 6. Not English speaking 7. Not biologically related to the unexposed sibling Unexposed cohort: 1. Gestational age under 36 weeks at birth 2. Any exposure to surgery or anesthesia prior to 36 months of age 3. Not categorized as ASA I or ASA II 4. Not ages 8 yr, 0 mo to 15 yr, 0 mo 5. Not English speaking 6. Not biologically related to the unexposed sibling

Additional Information

Official title Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) Study
Principal investigator Lena Sun, MD
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, 0mo to 15 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 will be administered to the sibling cohorts prospectively and parents of the siblings will complete parental interviews/questionnaires. We will 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 will also review medical records when appropriate. All testing will be performed during a one day site visit.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Columbia University.