General Anesthetics ToxicityGENIUSNCT03629093
Neurodevelopment of Infants Exposed to General Anesthesia: a Multi-center Investigation
An observational study of General Anesthetics Toxicity and Neurodevelopment, run by Huashan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 4 weeks to 2 years
- Conditions the study is for
- General Anesthetics Toxicity, Neurodevelopment, Infant
- What is being tested?
- General Anesthetics
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Apgar score ≥ 8 at birth
- ASA level Ⅰ~Ⅲ
- Obtained written consent form from the infants' parents or guardians
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Xiaoyu Yang, MD, 52889999
About this study
Official title: 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.
- Conditions
- General Anesthetics Toxicity, Neurodevelopment, Infant
- Being tested
- General Anesthetics
- Keywords
- General anesthesia, Infant, Neurodevelopment, Postoperative, the Gesell Developmental Inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnestheticsDrug
Also called General anesthesia
General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.
| Study group | Role | What they receive |
|---|---|---|
| Long-time anesthesia exposure | Infants receive general anesthetics longer than 3 hours in total. Receives: Drug: General Anesthetics | |
| Short-time anesthesia exposure | Infants receive general anesthetics shorter than 3 hours in total. Receives: Drug: General Anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline before anesthesia to 1 year after anesthesia
Secondary outcomes (2)
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.
Measured: 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.
Measured: From baseline before anesthesia to 1 year after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jan 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for General Anesthetics ToxicityStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Xiao-Yu Yang, MD, Huashan Hospital
- Investigators
- Ying-Wei Wang, M.D., Ph.D., Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629093
- Sponsor's protocol ID
- GENIUS
- Acronym
- GENIUS
- Status last verified
- Feb 2021
- First submitted
- 8 Aug 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26507180Graham 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.
PubMed 28915132Sun 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.
PubMed 27272582Warner 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.
PubMed 29672337
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Exposed Infants Neurodevelopment Investigation: a Multi-center Prospective Cohort Study United in Shanghai
- ClinicalTrials.gov ID
- NCT03629093
- Acronym / sponsor ID
- GENIUS / GENIUS
- Conditions
- General Anesthetics Toxicity, Neurodevelopment, Infant
- Keywords
- General anesthesia, Infant, Neurodevelopment, Postoperative, the Gesell Developmental Inventory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-time anesthesia exposure | – | Drug: General AnestheticsInfants receive general anesthetics longer than 3 hours in total. |
| Short-time anesthesia exposure | – | Drug: General AnestheticsInfants receive general anesthetics shorter than 3 hours in total. |
Who may qualify
- Ages
- 4 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Apgar score ≥ 8 at birth
- ASA level Ⅰ~Ⅲ
- Obtained written consent form from the infants' parents or guardians
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnestheticsAlso: General anesthesiaGeneral anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both. | Drug | Long-time anesthesia exposure, Short-time anesthesia exposure |
Primary outcome
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).
2 secondary outcomes
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
Change of the standardized score of the Social Maturity Scale
Time frame: From baseline before anesthesia to 1 year after anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 26507180Davidson 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.
- Background: PubMed 28915132Graham 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.
- Background: PubMed 27272582Sun 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.
- Background: PubMed 29672337Warner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Wei Wang, M.D., Ph.D. study director
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthetics Toxicity and Neurodevelopment, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Yu Yang, M.D. (52889999 ext. 7693, yangxiaoyu@huashan.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the developmental quotient of the Gesell Developmental Inventory (time frame: From baseline before anesthesia to 1 year after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629093, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.