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NCT Number: NCT04291274

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

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.

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Key information

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai No.9 People's Hospital, Shanghai, China

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2020
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.