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

Infant Clinical Trial

— GENIUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03629093
• Other study ID #: GENIUS
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2021
• Source: Huashan Hospital
• Contact: Xiao-Yu Yang, M.D.
• Phone: 52889999
• Email: yangxiaoyu[@]huashan.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Apgar score = 8 at birth
• ASA level ?~?
• 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

Related Conditions & MeSH terms

• General Anesthetics Toxicity
• Infant
• Neurodevelopment

Intervention

Drug:
• General Anesthetics
General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Huashan Hospital	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

Country where clinical trial is conducted

China, 

References & Publications (4)

Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4. Erratum in: Lancet. 2016 Jan 16;387(10015):228. — View Citation

Graham MR. Clinical update regarding general anesthesia-associated neurotoxicity in infants and children. Curr Opin Anaesthesiol. 2017 Dec;30(6):682-687. doi: 10.1097/ACO.0000000000000520. Review. — View Citation

Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967. — View Citation

Warner DO, Zaccariello MJ, Katusic SK, Schroeder DR, Hanson AC, Schulte PJ, Buenvenida SL, Gleich SJ, Wilder RT, Sprung J, Hu D, Voigt RG, Paule MG, Chelonis JJ, Flick RP. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology. 2018 Jul;129(1):89-105. doi: 10.1097/ALN.0000000000002232. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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