NCT03629093

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 4 Weeks – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• General Anesthetics Toxicity
• Neurodevelopment
• Infant

Interventions

Type	Name	Description
DRUG	General Anesthetics	General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-09-30
• Completion: 2024-12-30
• First posted: 2018-08-14
• Last updated: 2021-02-25

Locations

1 site across 1 country: China