NCT04431505

Brief Summary

Anesthetics cause widespread apoptosis in the developing brain, resulting in neurocognitive abnormalities. However, it is unknown whether anesthesia-induced neurotoxicity occurs in humans because there is currently no modality to assess for neuronal apoptosis in vivo

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

June 11, 2020

Last Update Submit

July 14, 2020

Conditions

Apoptosis

Outcome Measures

Primary Outcomes (1)

  • apoptotis during anaesthesia

    measuring markers of apoptosis pathway

    24 hours

Interventions

apoptosisOTHER

study of apoptotic changes due to anaesthesia

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

patients undergoing congenital heart corrective surgery

You may qualify if:

  • congenital heart corrective surgery

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Interventions

Apoptosis

Intervention Hierarchy (Ancestors)

Regulated Cell DeathCell DeathCell Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

June 12, 2020

Primary Completion

December 1, 2020

Study Completion

December 11, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

EG(1)