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The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment(Retrospective Research)

Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04291274
Enrollment
17
Registered
2020-03-02
Start date
2019-11-01
Completion date
2019-12-30
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Term Neurobehavioral Effects

Keywords

infant, anesthesia, neurobehavioral development

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.

Interventions

None listed

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 36 Months

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

Design outcomes

Primary

MeasureTime frameDescription
change of Baseline Gesell Developmental Scale after 6 monthchange 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026