Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- change of Baseline Gesell Developmental Scale after 6 month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
change of Baseline Gesell Developmental Scale after 6 month
时间窗: 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
次要结局
未报告次要终点
研究者
Jingjie Li
associate chief physician
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University