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

Long Term Neurobehavioral Effects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291274
• Other study ID #: SH9H-2019-T293-2
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Long Term Neurobehavioral Effects

Locations

Country	Name	City	State
China	Shanghai ninth people's hospital	Shanghai
China	Shanghai No.9 People's Hospital	Shanghai

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Baseline Gesell Developmental Scale after 6 month	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	change in 6 months after surgery]