NCT05803005

Brief Summary

Evaluate some Inflammatory markers \[IL-6, IL-8, TNF\_alpha\] in children with autism spectrum disorder

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

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

March 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 26, 2023

Last Update Submit

March 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • inflammatory marker in autism

    Evaluate some Inflammatory markers \[IL-6, IL-8, TNF\_alpha\] in children with autism spectrum disorder

    baseline

Study Arms (1)

children with autism spectrum disorder

: 50 patients aged 3\_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

Other: inflammatory marker in autism spectrum disorder

Interventions

Evaluate some Inflammatory markers \[IL-6, IL-8, TNF\_alpha\] in children with autism spectrum disorder

children with autism spectrum disorder

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

: 50 patients aged 3\_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

You may qualify if:

  • patients aged 3\_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

You may not qualify if:

  • : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • gehan kamal, prof.

    assiut universtiy

    STUDY DIRECTOR

Central Study Contacts

ghada ali, graduated

CONTACT

eman fathalla, ass.prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assiut

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 7, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

April 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share