PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
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.
Specific Aim: To compare neurocognitive functions in sibling pairs: one of whom had exposure to general anesthesia during surgery before 36 months of age (exposed cohort group) and who will be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study, and the other who never had any exposure to anesthesia or surgery less than 36 months of age (unexposed cohort group), who will be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study . Sibling pairs will be within 36 months of age from one another.
Cognition - Other
|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 The scale assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior.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 surgery 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.
Children who are siblings of the exposed children 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.
According to the National Hospital Discharge Survey, around 2.5 million children have surgical procedures requiring anesthesia each year in the US. The exposure to general anesthesia for children is much greater as many children receive general anesthesia for non-surgical procedures. Furthermore, there is an increased use of pediatric imaging studies requiring the use of sedation and anesthesia. The number of children having anesthesia is likely to grow substantially in the future. Given the extent of this growing pediatric exposure to anesthetics, it is disturbing that 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. Our goal is to determine whether the use of anesthetic agents in infants and children have long term adverse effects on neurocognitive development.
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|