PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
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.
Cognition - Other
Procedure: Inguinal hernia surgery
Procedure: General anesthesia
|Official Title:||Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) Study|
- Change in neurocognitive function [ Time Frame: Varies; when the participant is 8-15 years of age ] [ Designated as safety issue: No ]Global and Domain specific: Wechsler Abbreviated Scale of Intelligence (WASI) for global function. NEPSY II (A Developmental Neuropsychological Assessment), Weschler Intelligence Scale for Children (WISC-IV), California Verbal Learning Test-Children (CVLT-C), Continuous Performance Test-II(CPT-II), Delis-Kaplan Executive Function System (DKEFS)and Grooved pegboard test for domain-specific functions.
- Change in behavioral function [ Time Frame: Varies; when the participant is 8-15 years of age ] [ Designated as safety issue: No ]The CBCL obtains ratings of 113 problem items plus descriptions of problems, disabilities, parents' greatest concerns about their child, and the parent report of the "best things" about the child. The scale assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior. Behavior Rating Inventory of Executive Functions (BRIEF) assesses child's executive function and Adaptive Behavior Assessment System (ABAS-II) measures overall adaptive behavior and skills. Parenting Relationship Questionnaire (PRQ) explores parents' perspectives on parent-child relationship.
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Children who had inguinal hernia surgery and general anesthesia before 36 months of age (n=500). These children should be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study period.
Procedure: Inguinal hernia surgery
Non-experimental procedureProcedure: General anesthesia
Children who are siblings of the exposed children (inguinal hernia surgery and general anesthesia) and differ in age from the exposed children by less than 36 months and have no history of surgery or exposure to volatile and intravenous anesthetics or sedatives including barbiturates, benzodiazepines and chloral hydrate less than 36 months of age. These children should also be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study period.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881764
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Columbia University, 622 W. 168th St.|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Lena Sun, MD||Columbia University|