Infant Anesthesia Exposure and Neuro-outcome
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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 |
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Neurocognitive Function |
| Study Type: | Observational |
| Official Title: | Anesthesia Exposure and Neurodevelopment in Infants and Children |
- 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.
- 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 The scale assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior.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 |
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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.
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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.
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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 |
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.
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
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
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
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
Contacts and Locations| Contact: Lena Sun, MD | (212) 305-2413 | lss4@columbia.edu |
| Contact: Sena Han | (212) 305-6926 | sh2787@columbia.edu |
| 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: Michelle Chung michelle.chung@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@columbia.edu | |
| Contact: Sena Han 212-305-6926 sh2787@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 Goebelt 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 | Not yet recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Stephen Hays, MD 615-343-6223 stephen.hays@vanderbilt.edu | |
| Contact: Cleo Carter, MD cleo.carter@vanderbilt.edu | |
| Principal Investigator: Stephen Hayes, MD | |
| 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 14, 2012 |
| 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:
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Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013