NCT07208370

Brief Summary

This study analyze clinical and biological factors influencing disease course and outcome. Some research identified factors like disease severity, sensory symptoms, and autonomic instability as indicators of poor outcome. Ongoing research aims to develop accurate predictive models for improved treatment and care.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

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

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

September 15, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 15, 2025

Last Update Submit

September 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of Pediatric Patients with Guillain-Barré Syndrome Achieving Full Recovery within 3 Months

    Proportion of pediatric patients with Guillain-Barré Syndrome achieving full recovery, as assessed by the Hughes Functional Grading Scale, within 3 months of diagnosis.

    first 3 months after diagnosis

Study Arms (1)

GBS Group

EXPERIMENTAL
Other: clinical assessment

Interventions

standraized clinical evaluation to assess disease sevirity and progration

GBS Group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All Pediatric patients (1 month to 18 years old) admitted with acute flaccid ascending paralysis and diagnosed as GBS.
  • Consent obtained from parents or legal guardians for participation and follow-up.

You may not qualify if:

  • Children with pre-existing neuromuscular disorders. Patients with incomplete medical records or those lost to follow-up. Cases diagnosed as chronic inflammatory demyelinating polyneuropathy (CIDP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, Egypt

Location

Related Publications (5)

  • Kalita J, Kumar M, Misra UK. Prospective comparison of acute motor axonal neuropathy and acute inflammatory demyelinating polyradiculoneuropathy in 140 children with Guillain-Barre syndrome in India. Muscle Nerve. 2018 May;57(5):761-765. doi: 10.1002/mus.25992. Epub 2017 Nov 7.

    PMID: 29053890BACKGROUND
  • Koul RL, Alfutaisi A. Prospective study of children with Guillain-Barre syndrome. Indian J Pediatr. 2008 Aug;75(8):787-90. doi: 10.1007/s12098-008-0099-1. Epub 2008 Jun 25.

    PMID: 18581067BACKGROUND
  • Rajabally YA, Uncini A. Outcome and its predictors in Guillain-Barre syndrome. J Neurol Neurosurg Psychiatry. 2012 Jul;83(7):711-8. doi: 10.1136/jnnp-2011-301882. Epub 2012 May 7.

    PMID: 22566597BACKGROUND
  • Korinthenberg R. Acute polyradiculoneuritis: Guillain-Barre syndrome. Handb Clin Neurol. 2013;112:1157-62. doi: 10.1016/B978-0-444-52910-7.00036-2.

    PMID: 23622324BACKGROUND
  • Shahrizaila N, Yuki N. Antiganglioside antibodies in Guillain-Barre syndrome and its related conditions. Expert Rev Neurother. 2011 Sep;11(9):1305-13. doi: 10.1586/ern.11.114.

    PMID: 21864076BACKGROUND

Central Study Contacts

nourhan maher fawzy farah, principal investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 15, 2025

First Posted

October 6, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

Locations