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Completed

NCT Number: NCT00881764

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.

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Key information

Conditions

Cognition - Other

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Exposed cohort:

  • Subjects who had inguinal hernia surgery before 36 months of age
  • Ages 8 yr, 0 mo to 15 yr, 0 mo
  • Gestation age greater or equal to 36 weeks
  • Categorized as ASA I or ASA II
  • English speaking
  • Biologically related to the unexposed sibling

Unexposed cohort:

  • Sibling within 36 months of age of the exposed cohort
  • Never had surgery or exposure to anesthesia prior to 36 months of age
  • Ages 8 yr, 0 mo to 15 yr, 0 mo
  • Gestation age greater or equal to 36 weeks
  • Categorized as ASA I or ASA II
  • English speaking 6. Biologically related to the exposed sibling

Exclusion criteria

Exposed cohort:

  • Gestational age less than 36 weeks at birth
  • No exposure to surgery or anesthesia prior to 36 months of age
  • Surgery/Anesthesia other than index hernia repair prior to 36 months of age
  • Not categorized as ASA I or ASA II
  • Not ages 8 yr, 0 mo to 15 yr, 0 mo
  • Not English speaking
  • Not biologically related to the unexposed sibling

Unexposed cohort:

  • Gestational age under 36 weeks at birth
  • Any exposure to surgery or anesthesia prior to 36 months of age
  • Not categorized as ASA I or ASA II
  • Not ages 8 yr, 0 mo to 15 yr, 0 mo
  • Not English speaking
  • Not biologically related to the unexposed sibling

Treatment and study plan

Inguinal hernia surgery

Procedure

Non-experimental procedure

General Anesthesia

Procedure

Non-experimental procedure/treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Office of Acquisitions and Grants Services (OAGS)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Apr 15, 2009
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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