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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

April 14, 2009
November 10, 2014
April 2009
December 2016   (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 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.
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 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 The scale assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior.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.
  • 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 ]
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Infant Anesthesia Exposure and Neuro-outcome
Anesthesia Exposure and Neurodevelopment in Infants and Children

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.

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.

Observational
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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), 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.

Neurocognitive Function
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2016
December 2016   (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

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
Both
8 Years to 15 Years
Yes
Contact: Lena Sun, MD (212) 305-2413 lss4@columbia.edu
Contact: Sena Han (212) 305-6926 sh2787@columbia.edu
United States
 
NCT00881764
AAAC8756, R34HD060741, HHSF223200810036C
Yes
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 Sun, MD Columbia University
Columbia University
November 2014

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