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

February 23, 2021 updated by: Xiao-Yu Yang, MD, Huashan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
          • Xiaoyu Yang, MD
          • Phone Number: 52889999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Eligible infants scheduled for elective surgeries under general anesthesia will be recruited in six medical centers in Shanghai, China. The medical centers include Huashan Hospital Fudan University, Shanghai Children's Medical Center, Children's Hospital of Fudan University, Children's Hospital of Shanghai, Shanghai Tenth People's Hospital, and Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Long-time anesthesia exposure
Infants receive general anesthetics longer than 3 hours in total.
Drug: General Anesthetics
General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.
Other Names:
  • General anesthesia
Short-time anesthesia exposure
Infants receive general anesthetics shorter than 3 hours in total.
Drug: General Anesthetics
General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.
Other Names:
  • General anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the developmental quotient of the Gesell Developmental Inventory
Time Frame: From baseline before anesthesia to 1 year after anesthesia
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
Time Frame: From baseline before anesthesia to 1 year after anesthesia
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
Time Frame: From baseline before anesthesia to 1 year after anesthesia
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Collaborators

Children's Hospital of Fudan University
Shanghai Children's Hospital
Shanghai Children's Medical Center
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Ying-Wei Wang, M.D., Ph.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENIUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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