Anesthesia Related Neurocognitive Deficits in Children

NCT ID: NCT03034889

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exposed

Children age 4-10 who required general anesthesia before the age of 36 months in the context of surgical and diagnostic procedures or sedation during intensive care, excluding neurosurgical interventions or cardiac surgery as well as preexisting hereditary or acquired neurocognitive deficits

No interventions assigned to this group

Control

Children age 4-10 who did not require any anesthesia before the age of 36 months. Excluding preexisting hereditary or acquired neurocognitive deficits.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* General anesthesia before the age of 36 months

Exclusion Criteria

* neurosurgical interventions
* cardiac surgery
* preexisting hereditary or acquired cognitive deficits
* no informed consent
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tino Münster

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Erlangen, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANFOLKI-36

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Dexmedetomidine in Pediatric MRI
NCT05619627 NOT_YET_RECRUITING PHASE1
Citicoline as Neuroprotector in Preterm
NCT03966170 RECRUITING PHASE3