Clinical trial NCT04291274: The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment（Retrospective Research）
Official title: Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long Term Neurobehavioral Effects
Keywords: infant
anesthesia
neurobehavioral development
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing cochlear implantation under general anesthesia

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change of Baseline Gesell Developmental Scale after 6 month
timeFrame: change in 6 months after surgery]
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
city: Shanghai
country: China
facility: Shanghai No.9 People's Hospital
Study officials:
affiliation: Shanghai No.9 People's Hospital
name: Jingjie Li, M.D
role: STUDY_CHAIR
References:
citation: 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.