Clinical Trial: PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Columbia University

Current Primary Outcome: Change in neurocognitive function [ Time Frame: Varies; when the participant is 8-15 years of age ]

Global cognitive function: verbal, performance and full IQ assessed by Wechsler Abbreviated Scale of Intelligence (WASI). These are one unit of measure for IQ.


Original Primary Outcome: Global and Domain-specific Neurocognitive Function [ Time Frame: one day ]

Current Secondary Outcome:

  • Change in domain-specific function related to visual memory and learning [ Time Frame: Varies; when the participant is 8-15 years of age ]
    NEPSY II (A Developmental Neuropsychological Assessment) assesses visual memory learning
  • Change in domain-specific function related to verbal memory and learning [ Time Frame: Varies; when the participant is 8-15 years of age ]
    California Verbal Learning Test-Children (CVLT-C) assesses verbal memory and learning.
  • Change in domain-specific function related to receptive language [ Time Frame: Varies; when the participant is 8-15 years of age ]
    NEPSY II (A Developmental Neuropsychological Assessment) is used to assess receptive language and speeded naming.
  • Change in domain-specific function related to expressive language [ Time Frame: Varies; when the participant is 8-15 years of age ]
    WASI is used to assess expressive language and verbal reasoning
  • Change in domain-specific function related to working memory [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Weschler Intelligence Scale for Children (WISC-IV) is used to assess working memory, attention and executive function.
  • Change in domain-specific function related to all executive function components [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Behavior Rating In Executive Function (BRIEF) is used to assess all components of executive function.
  • Change in domain-specific function related to selective attention and impulsivity [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Continuous Performance Test-II (CPT-II) is used to assess sustained and selective attention as well as impulsivity.
  • Change in domain-specific function related to cognitive flexibility aspects of executive function [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Delis-Kaplan Executive Function System (DKEFS) is used to assess cognitive flexibility.
  • Change in domain-specific function related to motor and processing speed [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Grooved pegboard and Weschler Intelligence Scale for Children (WISC-IV) are used to assess motor and processing speed
  • Changes in behavior [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Childhood Behavior Check List (CBCL) assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior.
  • Changes in adaptive behavior [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Adaptive behavior is assessed using Adaptive Behavior Assessment Systems II (ABAS-II), which measures overall adaptive behavior and skills.
  • Changes in parental relationships [ Time Frame: Varies; when the participant is 8-15 years of age ]
    Parent Relationship Questionnaire (PRQ) is used to explore parents' perspectives on parent-child relationship.


Original Secondary Outcome:

  • Quality of life [ Time Frame: one day ]
  • Behavioral function [ Time Frame: one day ]
  • Emotional function [ Time Frame: one day ]
  • Neurological function [ Time Frame: one day ]
  • Family function [ Time Frame: one day ]


Information By: Columbia University

Dates:
Date Received: April 14, 2009
Date Started: May 2009
Date Completion:
Last Updated: February 1, 2016
Last Verified: February 2016