PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Office of Acquisitions and Grants Services (OAGS)
Information provided by (Responsible Party):
Lena S. Sun, Columbia University
ClinicalTrials.gov Identifier:
NCT00881764
First received: April 14, 2009
Last updated: February 1, 2016
Last verified: February 2016

April 14, 2009
February 1, 2016
May 2009
April 2015   (final data collection date for primary outcome measure)
Change in neurocognitive function [ Time Frame: Varies; when the participant is 8-15 years of age ] [ Designated as safety issue: No ]
Global cognitive function: verbal, performance and full IQ assessed by Wechsler Abbreviated Scale of Intelligence (WASI). These are one unit of measure for IQ.
Global and Domain-specific Neurocognitive Function [ Time Frame: one day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00881764 on ClinicalTrials.gov Archive Site
  • Change in domain-specific function related to visual memory and learning [ Time Frame: Varies; when the participant is 8-15 years of age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Parent Relationship Questionnaire (PRQ) is used to explore parents' perspectives on parent-child relationship.
  • Quality of life [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Behavioral function [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Emotional function [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Neurological function [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Family function [ Time Frame: one day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) 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.

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.

Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample
The study will be a multi-center study based at Columbia University with the following participating centers: Boston Children's (Harvard University), Children's Hospital of Philadelphia (University of Pennsylvania), Monroe Carell Children's Hospital (Vanderbilt University), and Morgan Stanley Children's Hospital of New York (Columbia University). Children exposed to anesthesia prior to 36 months must be ages 8 yr, 0 mo to 15 yr, 0 mo and have a sibling with no history of surgery or anesthesia prior to 36 months of age.
Cognition - Other
  • Procedure: Inguinal hernia surgery
    Non-experimental procedure
  • Procedure: General anesthesia
    Non-experimental procedure/treatment
  • Exposed Cohort
    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.
    Interventions:
    • Procedure: Inguinal hernia surgery
    • Procedure: General anesthesia
  • Unexposed Cohort
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
369
January 2016
April 2015   (final data collection date for primary outcome measure)

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
Both
8 Years to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00881764
AAAC8756, R34HD060741, HHSF223200810036C, SmartTots
No
Undecided
Not Provided
Lena S. Sun, Columbia University
Columbia University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Office of Acquisitions and Grants Services (OAGS)
Principal Investigator: Lena S Sun, MD Columbia University
Columbia University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP