Neurodevelopment of Infants Exposed to General Anesthesia: a Multi-center Investigation

Study Overview
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Brief Summary
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Numerous preclinical evidence has confirmed that most commonly-used general anesthetics can affect neurodevelopment of young animals adversely, causing both structural defect of brain and cognitive impairment. However, it is unclear at present whether such effect would also occur to children exposed to general anesthesia in their early life. Several observational clinical studies and one interventional clinical trial indicated that short-time general anesthesia less than 80 minutes might be safe to cognitive development. Concerning long-time and/or multiple anesthesia exposure, some studies supported its association with long-term cognitive defects, while other studies did not. These studies are mainly retrospective or ambirectional researches. We have designed a prospective, multicenter cohort study to examine the neurodevelopment of infants exposed to anesthesia before age 2 in the first year after surgery, and compare the neurodevelopment status of infants exposed to anesthesia less than 3 hours and those more than 3 hours. The Gesell Developmental Inventory (GDI) and several neuropsychological testing batteries will be used. The anticipated outcome of the study will add reliable evidence from Asians to elucidate the relationship of anesthesia and long-term neurodevelopment of infants.

Official Title
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General Anesthesia Exposed Infants Neurodevelopment Investigation: a Multi-center Prospective Cohort Study United in Shanghai

Conditions
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General Anesthetics Toxicity, Neurodevelopment, Infant

Intervention / Treatment
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* Drug: General Anesthetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apgar score ≥ 8 at birth ASA level Ⅰ Ⅲ Obtained written consent form from the infants' parents or guardians Exclusion Criteria: Postmenstrual age ≤ 44 weeks, or postmenstrual age ≥ 144 weeks Severe cardiac, pulmonary, or neurologic disease Severe obstructive sleep apnea hypopnea syndrome History of dystocia and/or hypoxic ischemic encephalopathy Gestational age at birth ≤32 weeks Any known or suspected chromosomal abnormalities, abnormal development of vision or hearing, neurodevelopment retardation, or other known acquired or congenital abnormalities that might affect neurodevelopment Significant cardiovascular surgery, significant ENT surgery, or neurosurgery Malignant diseases that may reduce survival Taking part in other clinical trials in the last 3 months or at present

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-time anesthesia exposure<br>Infants receive general anesthetics longer than 3 hours in total. | Drug: General Anesthetics<br>* General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.<br>* Other names: General anesthesia;|
| Short-time anesthesia exposure<br>Infants receive general anesthetics shorter than 3 hours in total. | Drug: General Anesthetics<br>* General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.<br>* Other names: General anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the developmental quotient of the Gesell Developmental Inventory | The Gesell Developmental Inventory has been translated into Chinese and standardized by the Beijing Children's Health Care Institute and the performance results are expressed as a developmental quotient (DQ). | From baseline before anesthesia to 1 year after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the standardized score of the five domains of the Gesell Developmental Inventory | The five behavioral domains are gross motor, fine motor, language, adaptive, and personal-social behaviors. | From baseline before anesthesia to 1 year after anesthesia | 
| Change of the standardized score of the Social Maturity Scale | The Social Maturity Scale includes six domains and 132 questions designed to be completed by the parents. | From baseline before anesthesia to 1 year after anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anesthesia, Infant, Neurodevelopment, Postoperative, the Gesell Developmental Inventory