Long Term Neurobehavioral EffectsNCT04291274
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment（Retrospective Research）
An observational study of Long Term Neurobehavioral Effects, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites 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 to 36 months
- Conditions the study is for
- Long Term Neurobehavioral Effects
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2019to 30 Dec 2019
- 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 to 36 months
- All sexes
- Child
Study population: Children undergoing cochlear implantation under general anesthesia
Who may be able to join
- Children undergoing cochlear implantation under general anesthesia
- 6 to 36-month-old child
- Normal body weight
- Children with normal structures of the inner ear and auditory nerve
- Children without contraindications to anesthesia and surgery
- Patients who have not participated in other clinical trials
- Without any acute infectious diseases or systematic diseases
Who cannot join
- The participants with a Gesell score (fine motor and gross motor) lower than 86 after preoperative evaluation.
- With other illness which could affects curative effect of recovery, such as inner ear malformations (except for large vestibular aqueduct syndrome), auditory vestibular nerve dysplasia, dysgnosia and mental disease;
- Inability to cooperate with the hearing evaluation and the language training
- Cute and chronic otitis media and mastoiditis, unhealed tympanic membrane perforation
- Abnormal structure of brain, including white matter dysplasia, Demyelinating Diseases
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai ninth people's hospital
Shanghai
Shanghai No.9 People's Hospital
Shanghai
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 intravenous or inhalation anesthesia by a ambispective cohort study.
Read the detailed description
Gesell development scale contains five subscales including adaptability, fine motor, gross motor, language, and social skill evaluation. Developmental quotient (DQ) = (development age/actual age)×100. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ ≤54 is moderate neurological damage, 25 B DQ B 39 is severe neurological damage, and DQ< 25 is very severe neurological damage.
- 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 |
|---|---|---|
| inhalation anesthesia group | Unilateral and Bilateral cochlear implantation,which used inhalation anesthesia | |
| intravenous anesthesia group | Unilateral and Bilateral cochlear implantation, which used intravenous anesthesia |
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 was measured use Gesell Developmental Scale. DQ (Developmental quotient) was calculated by (development age/actual age)×100. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ≤54 is moderate neurological damage, 25≤DQ≤39 is severe neurological damage, and DQ <25 is very severe neurological damage
Measured: change in 6 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 posted2 Mar 2020
- Study start1 Nov 2019
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
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
- Retrospective
- Enrolment
- 17 participants (actual)
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
- NCT04291274
- Sponsor's protocol ID
- SH9H-2019-T293-2
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, Cheng Y, Xue Z, Li J, Wu N, Yan J, Wang J, Wang C, Chen W, Zhou T, Qiu Z, Jiang H. Sevoflurane impairs m6A-mediated mRNA translation and leads to fine motor and cognitive deficits. Cell Biol Toxicol. 2022 Apr;38(2):347-369. doi: 10.1007/s10565-021-09601-4. Epub 2021 Apr 29.
PubMed 33928466
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. 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
- NCT04291274
- Acronym / sponsor ID
- SH9H-2019-T293-2
- Conditions
- Long Term Neurobehavioral Effects
- Keywords
- infant, anesthesia, neurobehavioral development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 2 Mar 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 intravenous or inhalation anesthesia by a ambispective cohort study.
Detailed description
Gesell development scale contains five subscales including adaptability, fine motor, gross motor, language, and social skill evaluation. Developmental quotient (DQ) = (development age/actual age)×100. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ ≤54 is moderate neurological damage, 25 B DQ B 39 is severe neurological damage, and DQ< 25 is very severe neurological damage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhalation anesthesia group | – | –Unilateral and Bilateral cochlear implantation,which used inhalation anesthesia |
| intravenous anesthesia group | – | –Unilateral and Bilateral cochlear implantation, which used intravenous anesthesia |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Age groups
- Child
- Study population
- Children undergoing cochlear implantation under general anesthesia
Key inclusion criteria (7 listed)
- Children undergoing cochlear implantation under general anesthesia
- 6 to 36-month-old child
- Normal body weight
- Children with normal structures of the inner ear and auditory nerve
- Children without contraindications to anesthesia and surgery
Key exclusion criteria (5 listed)
- The participants with a Gesell score (fine motor and gross motor) lower than 86 after preoperative evaluation.
- With other illness which could affects curative effect of recovery, such as inner ear malformations (except for large vestibular aqueduct syndrome), auditory vestibular nerve dysplasia, dysgnosia and mental disease;
- Inability to cooperate with the hearing evaluation and the language training
- Cute and chronic otitis media and mastoiditis, unhealed tympanic membrane perforation
- Abnormal structure of brain, including white matter dysplasia, Demyelinating Diseases
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 was measured use Gesell Developmental Scale. DQ (Developmental quotient) was calculated by (development age/actual age)×100. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ≤54 is moderate neurological damage, 25≤DQ≤39 is severe neurological damage, and DQ <25 is very severe neurological damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Derived from this study: PubMed 33928466Zhang L, Cheng Y, Xue Z, Li J, Wu N, Yan J, Wang J, Wang C, Chen W, Zhou T, Qiu Z, Jiang H. Sevoflurane impairs m6A-mediated mRNA translation and leads to fine motor and cognitive deficits. Cell Biol Toxicol. 2022 Apr;38(2):347-369. doi: 10.1007/s10565-021-09601-4. Epub 2021 Apr 29.
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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.
Jingjie Li, M.D study chair
Shanghai No.9 People's Hospital
2 sites 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 2 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04291274, 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 20 Sep 2021.