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Infant Anesthesia Exposure and Neuro-outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Columbia University
Sponsor:
Collaborators:
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: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition
Neurocognitive Function

Study Type: Observational
Official Title: Anesthesia Exposure and Neurodevelopment in Infants and Children

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 The scale assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior.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.


Estimated Enrollment: 1000
Study Start Date: April 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposed Cohort
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.
Unexposed Cohort
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will be a multi-center study based at Columbia University with the following participating centers: Boston Children's (Harvard University), Chicago Children's Memorial (Northwestern University), Children's Hospital of Philadelphia (University of Pennsylvania), Cincinnati Children's Hospital (University of Cincinnati College of Medicine), University of Pittsburgh Children's Hospital, University of Michigan Children's Hospital, 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.

Criteria

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

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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881764

Contacts
Contact: Lena Sun, MD (212) 305-2413 lss4@columbia.edu
Contact: Sena Han (212) 305-6926 sh2787@columbia.edu

Locations
United States, Illinois
Children's Memorial Hospital Not yet recruiting
Chicago, Illinois, United States, 60614
Contact: Santhanam Suresh, MD    773-975-8705    ssuresh@childrensmemorial.org   
Principal Investigator: Santhanam Suresh, MD         
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tonya Miller, MD    617-335-4369    tonya.miller@childrens.harvard.edu   
Contact: Rachel Bernier       Rachel.Bernier@childrens.harvard.edu   
Principal Investigator: Tonya Miller, MD         
United States, Michigan
Mott Children's Hospital (University of Michigan) Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shobha Malviya, MD         
Principal Investigator: Shobha Malviya, MD         
United States, New York
Columbia University, 622 W. 168th St. Recruiting
New York, New York, United States, 10032
Contact: Lena Sun, MD    212-305-2413    lss4@cumc.columbia.edu   
Contact: Sena Han    212-305-6926    sh2787@cumc.columbia.edu   
Principal Investigator: Lena Sun, MD         
United States, Ohio
Cincinnati Children's Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Andreas W. Loepke, MD, PhD, FAAP    513-636-4408    Andreas.Loepke@cchmc.org   
Principal Investigator: Andreas W. Loepke, MD, PhD, FAAP         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lynne G. Maxwell, MD, FAAP         
Contact: Theodora Goebel       goebelt@email.chop.edu   
Principal Investigator: Lynne G. Maxwell, MD, FAAP         
University of Pittsburgh Children's Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Peter Davis, MD       davispj@anes.upmc.edu   
Principal Investigator: Peter Davis, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Stephen Hays, MD    615-343-6223    stephen.hays@vanderbilt.edu   
Contact: Kiersten Card       kiersten.k.card@vanderbilt.edu   
Principal Investigator: Stephen Hayes, MD         
Sponsors and Collaborators
Columbia University
Office of Acquisitions and Grants Services (OAGS)
Investigators
Principal Investigator: Lena Sun, MD Columbia University
  More Information

Publications:
Responsible Party: Lena S. Sun, Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT00881764     History of Changes
Other Study ID Numbers: AAAC8756, R34HD060741, HHSF223200810036C
Study First Received: April 14, 2009
Last Updated: November 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Anesthesia
New York
Columbia
Children
Neurodevelopment
Child development
Pediatric

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014