The Neurobehavioral Effects of Anesthetics on Infants Wit... | NCT04255485

Studies
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

NCT04255485

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 6, 2020Actual

Enrollment

52Estimated

Phase

Not provided

Conditions

Long Term Neurobehavioral Effects

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2019Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jan 26, 2020

First Submission Date that Met QC Criteria

Jan 31, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2020

Last Update Posted Date

Mar 6, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jingjie Li, associate chief physician, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 unilateral or bilateral cochlear implantation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Short time anesthesia group		Unilateral cochlear implantation,which time of anesthesia is less than 3 hours
Long time anesthesia group		Bilateral cochlear implantation, which time of anesthesia is more than 3 hours

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of Baseline Gesell Developmental Scale after 6 month	Neurobehavior effects	change in 6 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
change of Baseline Gesell Developmental Scale after 12 month	Neurobehavior effects	change in 12 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital
Patients who have not participated in other clinical trials
ASA class I-II selective operation without any acute infectious diseases or systematic diseases
Infant's family members agree to participated in the trials and sign the informed consent

Exclusion Criteria:

Reject to sign the informed consent and participate in the trials
Patients with severe liver and kidney damage or other heart, lung and nervous system diseases
The Gesell developmental scale is less than 86 in motor behavior and physical energy
With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice
Infant who is allergic to egg and milk
Family history of malignant hyperthermia
Allergy to anesthetic drugs

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

2 Years

Standard Ages

Child

Study Population

Children undergoing cochlear implantation under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jingjie Li, M.D	Contact	86-18019790516		116212@sh9hospital.org
Lei Zhang, Ph.D	Contact

Overall Officials

Name	Affiliation	Role
Jingjie Li, M.D	Shanghai No.9 People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai No.9 People's Hospital	Recruiting	Shanghai			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37574593	Derived	Ma L, Yu Y, Zhou X, Shi J, Le N, Liang Y, Li J, Jiang H. Neurobehavioral effects of general anesthesia and cochlear implantation on hearing-impaired infants: A prospective observational cohort study. Brain Behav. 2023 Oct;13(10):e3216. doi: 10.1002/brb3.3216. Epub 2023 Aug 13.