NCT03180112

Brief Summary

Autism spectrum disorders are pervasive developmental disorders that include autistic disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise specified.They are characterized by stereotypic behaviors, variable deficits in language and social skills and a wide range of other behavioral problems. Autism spectrum disorders manifest during childhood and at least thirty percent present with sudden clinical regression of development around three years of age.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

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 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

June 1, 2017

Last Update Submit

June 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • relationship between herpes simplex viruses infections and development of autism.

    Detection of herpes simplex viruses antibody titre by sensitive enzyme linked immunosorbent assay and detection of herpes simplex viruses titre by quantitative polymerase chain reaction

    12 month

Study Arms (2)

case group

Children suffering from Autism Spectrum disorders of variable grades attending to assiut University Children Hospital aged between six months and five years.

Genetic: enzyme linked immunosorbent assay and polymerase chain reaction

control group

Healthy children of matching age and sex.

Genetic: enzyme linked immunosorbent assay and polymerase chain reaction

Interventions

Blood samples will be collected and analyzed for herpes simplex viruses (type one and two) antibody by sensitive enzyme-linked immunosorbent assay and quantitative polymerase chain reaction.

case groupcontrol group

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children suffering from Autism Spectrum disorders of variable grades attending to Assuit University Children Hospital and the same number of healthy children of matching age and sex as a control. Age between six months and five years

You may qualify if:

  • Children suffering from Autism spectrum disorders.
  • Age between six months and five years

You may not qualify if:

  • Genetic disorders.
  • History of metabolic or neurodegenerative disease.
  • Gross motor delay.
  • Audiologic problems.
  • Mental retardation.
  • Other psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Johnson CP, Myers SM; American Academy of Pediatrics Council on Children With Disabilities. Identification and evaluation of children with autism spectrum disorders. Pediatrics. 2007 Nov;120(5):1183-215. doi: 10.1542/peds.2007-2361. Epub 2007 Oct 29.

    PMID: 17967920BACKGROUND
  • Zappella M. Autistic regression with and without EEG abnormalities followed by favourable outcome. Brain Dev. 2010 Oct;32(9):739-45. doi: 10.1016/j.braindev.2010.05.004. Epub 2010 Aug 12.

    PMID: 20708360BACKGROUND
  • Fombonne E. Epidemiology of pervasive developmental disorders. Pediatr Res. 2009 Jun;65(6):591-8. doi: 10.1203/PDR.0b013e31819e7203.

    PMID: 19218885BACKGROUND
  • Libbey JE, Sweeten TL, McMahon WM, Fujinami RS. Autistic disorder and viral infections. J Neurovirol. 2005 Feb;11(1):1-10. doi: 10.1080/13550280590900553.

    PMID: 15804954BACKGROUND
  • DeLong GR, Bean SC, Brown FR 3rd. Acquired reversible autistic syndrome in acute encephalopathic illness in children. Arch Neurol. 1981 Mar;38(3):191-4. doi: 10.1001/archneur.1981.00510030085013.

    PMID: 6162440BACKGROUND
  • Gillberg C. Onset at age 14 of a typical autistic syndrome. A case report of a girl with herpes simplex encephalitis. J Autism Dev Disord. 1986 Sep;16(3):369-75. doi: 10.1007/BF01531665. No abstract available.

    PMID: 3558293BACKGROUND
  • Ghaziuddin M, Tsai LY, Eilers L, Ghaziuddin N. Brief report: autism and herpes simplex encephalitis. J Autism Dev Disord. 1992 Mar;22(1):107-13. doi: 10.1007/BF01046406. No abstract available.

    PMID: 1592760BACKGROUND
  • Hetzler BE, Griffin JL. Infantile autism and the temporal lobe of the brain. J Autism Dev Disord. 1981 Sep;11(3):317-30. doi: 10.1007/BF01531514.

    PMID: 6189814BACKGROUND
  • Dalod M, Salazar-Mather TP, Malmgaard L, Lewis C, Asselin-Paturel C, Briere F, Trinchieri G, Biron CA. Interferon alpha/beta and interleukin 12 responses to viral infections: pathways regulating dendritic cell cytokine expression in vivo. J Exp Med. 2002 Feb 18;195(4):517-28. doi: 10.1084/jem.20011672.

    PMID: 11854364BACKGROUND
  • Salazar-Mather TP, Hamilton TA, Biron CA. A chemokine-to-cytokine-to-chemokine cascade critical in antiviral defense. J Clin Invest. 2000 Apr;105(7):985-93. doi: 10.1172/JCI9232.

    PMID: 10749577BACKGROUND
  • Legaspi RC, Gatmaitan B, Bailey EJ, Lerner AM. Interferon in biopsy and autopsy specimens of brain. Its presence in herpes simplex virus encephalitis. Arch Neurol. 1980 Feb;37(2):76-9. doi: 10.1001/archneur.1980.00500510034004.

    PMID: 7356411BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

quantitative polymerase chain reaction.

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Enzyme-Linked Immunosorbent AssayPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe TechniquesNucleic Acid Amplification TechniquesGenetic Techniques

Central Study Contacts

Gamal Ali Abdelal, MD

CONTACT

Eman Ahmed Abdelraof, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 8, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share