Long Term Neurobehavioral EffectsNCT04255485
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment
An observational study of Long Term Neurobehavioral Effects, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment… Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Long Term Neurobehavioral Effects
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to 31 Dec 2021
- 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 6 months to 2 years
- All sexes
- Child
Study population: Children undergoing cochlear implantation under general anesthesia
Who may be able to join
- Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital
- Patients who have not participated in other clinical trials
- ASA class I-II selective operation without any acute infectious diseases or systematic diseases
- Infant's family members agree to participated in the trials and sign the informed consent
Who cannot join
- Reject to sign the informed consent and participate in the trials
- Patients with severe liver and kidney damage or other heart, lung and nervous system diseases
- The Gesell developmental scale is less than 86 in motor behavior and physical energy
- With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice
- Infant who is allergic to egg and milk
- Family history of malignant hyperthermia
- Allergy to anesthetic drugs
Trial locations and contacts
1 site in 1 country.
Lei Zhang, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Shanghai No.9 People's Hospital
Shanghai
Jingjie Li, M.D, 18019790516, 116212@sh9hospital.org
Hong Jiang, Prof.
About this study
Official title: Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.
- Conditions
- Long Term Neurobehavioral Effects
- Keywords
- infant, anesthesia, neurobehavioral development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short time anesthesia group | Unilateral cochlear implantation,which time of anesthesia is less than 3 hours | |
| Long time anesthesia group | Bilateral cochlear implantation, which time of anesthesia is more than 3 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Baseline Gesell Developmental Scale after 6 month
Neurobehavior effects
Measured: change in 6 months after surgery
Secondary outcomes (1)
change of Baseline Gesell Developmental Scale after 12 month
Neurobehavior effects
Measured: change in 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Apr 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long Term Neurobehavioral EffectsStudies 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
- Other
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Jingjie Li, M.D, Study chair, Shanghai No.9 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255485
- Sponsor's protocol ID
- SH9H-2019-T19-2
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma L, Yu Y, Zhou X, Shi J, Le N, Liang Y, Li J, Jiang H. Neurobehavioral effects of general anesthesia and cochlear implantation on hearing-impaired infants: A prospective observational cohort study. Brain Behav. 2023 Oct;13(10):e3216. doi: 10.1002/brb3.3216. Epub 2023 Aug 13.
PubMed 37574593
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
- ClinicalTrials.gov ID
- NCT04255485
- Acronym / sponsor ID
- SH9H-2019-T19-2
- Conditions
- Long Term Neurobehavioral Effects
- Keywords
- infant, anesthesia, neurobehavioral development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Feb 2020 (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.
The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short time anesthesia group | – | –Unilateral cochlear implantation,which time of anesthesia is less than 3 hours |
| Long time anesthesia group | – | –Bilateral cochlear implantation, which time of anesthesia is more than 3 hours |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- Children undergoing cochlear implantation under general anesthesia
Key inclusion criteria (4 listed)
- Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital
- Patients who have not participated in other clinical trials
- ASA class I-II selective operation without any acute infectious diseases or systematic diseases
- Infant's family members agree to participated in the trials and sign the informed consent
Key exclusion criteria (7 listed)
- Reject to sign the informed consent and participate in the trials
- Patients with severe liver and kidney damage or other heart, lung and nervous system diseases
- The Gesell developmental scale is less than 86 in motor behavior and physical energy
- With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice
- Infant who is allergic to egg and milk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of Baseline Gesell Developmental Scale after 6 month
Time frame: change in 6 months after surgery
Neurobehavior effects
1 secondary outcome
change of Baseline Gesell Developmental Scale after 12 month
Time frame: change in 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 37574593Ma L, Yu Y, Zhou X, Shi J, Le N, Liang Y, Li J, Jiang H. Neurobehavioral effects of general anesthesia and cochlear implantation on hearing-impaired infants: A prospective observational cohort study. Brain Behav. 2023 Oct;13(10):e3216. doi: 10.1002/brb3.3216. Epub 2023 Aug 13.
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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.
Lei Zhang, Ph.D contact
Jingjie Li, M.D study chair
Shanghai No.9 People's 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 Long Term Neurobehavioral Effects, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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 Jingjie Li, M.D (86-18019790516, 116212@sh9hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Baseline Gesell Developmental Scale after 6 month (time frame: change in 6 months after surgery). 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 NCT04255485, which also lists 1 linked publication.
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 6 Mar 2020.