Neurodevelopmental DelayNCT06367062
General Anesthesia/Surgical Exposure on White Matter Development in Children
An observational study of Neurodevelopmental Delay, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Neurodevelopmental Delay
- What is being tested?
- MRI
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 15 years
- All sexes
- Child
Study population: Age between 12-15 years.Past history doesn't lead to abnormal brain development.
Who may be able to join
- Currently between 12 and 15 years of age
Who cannot join
- Surgical complications such as acute infectious diseases, systemic diseases
- Abnormal findings on cerebral white matter and/or neurobehavioral assessment
- History of neonatal ischemic-hypoxic encephalopathy, bilirubin encephalopathy
- Genetic or chromosomal disorders, neurological disorders (including epilepsy, congenital disorders), or a history of craniocerebral trauma, infectious diseases of the central nervous system, febrile convulsions, congenital heart disease, oncological diseases, and blood disorders
- Autism, attention deficit hyperactivity disorder, or those who have received behavioral therapy and intervention.
- Children with organic damage to the nervous system
- Cardiovascular surgery, neurosurgery or intraoperative hemodynamic instability.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of the Effects of General Anesthesia/Surgical Exposure on Distant Cerebral White Matter Development in Children
International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development.
- Conditions
- Neurodevelopmental Delay
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI is used to assess of brain development.
| Study group | Role | What they receive |
|---|---|---|
| Multiple anesthesia group | Children who underwent more than one general anesthesia procedure between the ages of 0-3 years. Receives: Other: MRI | |
| Single anesthesia group | Children who underwent only one general anesthesia procedure between the ages of 0-3 years. Receives: Other: MRI | |
| Control group | Children who underwent no general anesthesia procedure between the ages of 0-3 years. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-based assessment of brain development
Magnetic resonance scanning of T1-weighted images, T2-weighted images, and diffusion tensor imaging (DTI) of both cerebral hemispheres, looking at whole-brain white matter volume as a percentage of total intracranial volume
Measured: one time, through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DelayStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367062
- Sponsor's protocol ID
- SH9H-2023-T296
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of General Anesthesia/Surgical Exposure on Distant Cerebral White Matter Development in Children
- ClinicalTrials.gov ID
- NCT06367062
- Acronym / sponsor ID
- SH9H-2023-T296
- Conditions
- Neurodevelopmental Delay
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2024 (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.
International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple anesthesia group | – | Other: MRIChildren who underwent more than one general anesthesia procedure between the ages of 0-3 years. |
| Single anesthesia group | – | Other: MRIChildren who underwent only one general anesthesia procedure between the ages of 0-3 years. |
| Control group | – | Other: MRIChildren who underwent no general anesthesia procedure between the ages of 0-3 years. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Age between 12-15 years.Past history doesn't lead to abnormal brain development.
Key inclusion criteria (1 listed)
- Currently between 12 and 15 years of age
Key exclusion criteria (7 listed)
- Surgical complications such as acute infectious diseases, systemic diseases
- Abnormal findings on cerebral white matter and/or neurobehavioral assessment
- History of neonatal ischemic-hypoxic encephalopathy, bilirubin encephalopathy
- Genetic or chromosomal disorders, neurological disorders (including epilepsy, congenital disorders), or a history of craniocerebral trauma, infectious diseases of the central nervous system, febrile convulsions, congenital heart disease, oncological diseases, and blood disorders
- Autism, attention deficit hyperactivity disorder, or those who have received behavioral therapy and intervention.
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 |
|---|---|---|
| MRIMRI is used to assess of brain development. | Other | Control group, Multiple anesthesia group, Single anesthesia group |
Primary outcome
MRI-based assessment of brain development
Time frame: one time, through study completion, an average of 3 month
Magnetic resonance scanning of T1-weighted images, T2-weighted images, and diffusion tensor imaging (DTI) of both cerebral hemispheres, looking at whole-brain white matter volume as a percentage of total intracranial volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Delay, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang (+8618717822662, weiymzhl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-based assessment of brain development (time frame: one time, through study completion, an average of 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.