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NCT04255485

The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

Status unknown Last updated 6 March 2020
What this trial tests

trial in Long Term Neurobehavioral Effects in 52 participants. Status unknown.

Timeline
8 April 2019
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment52
Start date8 April 2019
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across China

Conditions studied

Sponsor

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

Who can join

Adults 6 Months to 2, any sex, with Long Term Neurobehavioral Effects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Neurobehavioral effects of general anesthesia and cochlear implantation on hearing-impaired infants: A prospective observational cohort study.
    Ma L, Yu Y, Zhou X, Shi J, et al · · 2023 · cited 1× · PMID 37574593 · DOI 10.1002/brb3.3216

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