PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 15 |
| Updated: | 7/25/2018 |
| Start Date: | May 2009 |
| End Date: | January 2016 |
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.
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.
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.
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
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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