NCT06300359

Brief Summary

Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

February 21, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

Prognostic indicators

Outcome Measures

Primary Outcomes (1)

  • Prognostic indicators of Gullian-Barre syndrome

    The predictive factors with worse prognosis

    Baseline

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with GBS, presenting with weakness, diagnosed on clinical and/or electrophysiological grounds, were enrolled. The enrolled children underwent a detailed clinical-assessment followed by nerve conduction studies.

You may qualify if:

  • Patients 2 - 18 years old with guillian barrie syndrome admitted at Assiut university children hospital.
  • Acceptance to participate in this study .

You may not qualify if:

  • Patients aged less than 2 years and more than 18 years old . Children or Parents who refused to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.

    PMID: 25023340BACKGROUND
  • The prognosis and main prognostic indicators of Guillain-Barre syndrome. A multicentre prospective study of 297 patients. The Italian Guillain-Barre Study Group. Brain. 1996 Dec;119 ( Pt 6):2053-61.

    PMID: 9010009BACKGROUND
  • van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.

    PMID: 18848313BACKGROUND
  • Gonzalez-Suarez I, Sanz-Gallego I, Rodriguez de Rivera FJ, Arpa J. Guillain-Barre syndrome: natural history and prognostic factors: a retrospective review of 106 cases. BMC Neurol. 2013 Jul 22;13:95. doi: 10.1186/1471-2377-13-95.

    PMID: 23876199BACKGROUND
  • Kuwabara S. Guillain-Barre syndrome: epidemiology, pathophysiology and management. Drugs. 2004;64(6):597-610. doi: 10.2165/00003495-200464060-00003.

    PMID: 15018590BACKGROUND
  • Leonhard SE, Mandarakas MR, Gondim FAA, Bateman K, Ferreira MLB, Cornblath DR, van Doorn PA, Dourado ME, Hughes RAC, Islam B, Kusunoki S, Pardo CA, Reisin R, Sejvar JJ, Shahrizaila N, Soares C, Umapathi T, Wang Y, Yiu EM, Willison HJ, Jacobs BC. Diagnosis and management of Guillain-Barre syndrome in ten steps. Nat Rev Neurol. 2019 Nov;15(11):671-683. doi: 10.1038/s41582-019-0250-9. Epub 2019 Sep 20.

    PMID: 31541214BACKGROUND
  • Mani AM, Prabhakar AT, Alexander PT, Nair A, Vijayaraghavan A, Shaikh A, Benjamin R, Sivadasan A, Mathew V, Aaron S, Alexander M. Utility of Serial Nerve Conduction Studies in the Electrodiagnosis of Guillain-Barre Syndrome. Neurol India. 2021 Mar-Apr;69(2):369-375. doi: 10.4103/0028-3886.314529.

    PMID: 33904455BACKGROUND
  • Nagappa M, Netto AB, Taly AB, Kulkarni GB, Umamaheshwara Rao GS, Periyavan S, Rao S. Electrophysiological observations in critically ill Guillain-Barre syndrome. Neurol India. 2016 Sep-Oct;64(5):914-20. doi: 10.4103/0028-3886.190271.

    PMID: 27625229BACKGROUND
  • Rangan RS, Tullu MS, Deshmukh CT, Mondkar SA, Agrawal M. Clinical Profile and Outcome of Guillain-Barre Syndrome in Pediatric Patients Admitted to a Tertiary Care Centre: A Retrospective Study. Neurol India. 2021 Jan-Feb;69(1):81-84. doi: 10.4103/0028-3886.310112.

    PMID: 33642275BACKGROUND
  • Zhang Y, Zhao Y, Wang Y. Prognostic factors of Guillain-Barre syndrome: a 111-case retrospective review. Chin Neurosurg J. 2018 Jun 18;4:14. doi: 10.1186/s41016-018-0122-y. eCollection 2018.

    PMID: 32922875BACKGROUND
  • Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.

    PMID: 1745285BACKGROUND
  • Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980 Jun;36(2):343-6.

    PMID: 26625475BACKGROUND

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amira A Sayed Amin, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Gamal A Abdelaal Asker, Professor

    Assiut University

    STUDY DIRECTOR
  • Azhar A Mohammed Mohammed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Amira A Sayed, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal Investigator

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 8, 2024

Study Start

March 1, 2024

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share