PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study

Completed

• Conditions: Cognition - Other
• Interventions: Procedure: Inguinal hernia surgery; Procedure: General anesthesia

• Registration Number: NCT00881764
• Lead Sponsor: Columbia University

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 Description

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.

Study Timeline

• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Study Start: 2009-05
• Primary Completion: 2015-04
• Study Completion: 2016-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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

6. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed Cohort	Inguinal hernia surgery	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.
Exposed Cohort	General anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Change in neurocognitive function	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 Outcome Measures

Name	Time	Method
Change in domain-specific function related to visual memory and learning	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 working memory	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 cognitive flexibility aspects of executive function	Varies; when the participant is 8-15 years of age	Delis-Kaplan Executive Function System (DKEFS) is used to assess cognitive flexibility.
Changes in adaptive behavior	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.
Change in domain-specific function related to receptive language	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.
Changes in parental relationships	Varies; when the participant is 8-15 years of age	Parent Relationship Questionnaire (PRQ) is used to explore parents' perspectives on parent-child relationship.
Changes in behavior	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.
Change in domain-specific function related to verbal memory and learning	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 motor and processing speed	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
Change in domain-specific function related to expressive language	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 all executive function components	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	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.

Trial Locations

Locations (4)

Columbia University, 622 W. 168th St.; 🇺🇸 New York, New York, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States