NCT07842705

Brief Summary

This prospective cohort study aims to identify and characterize cardiac changes including electrocardiographic, echocardiographic, and biochemical abnormalities in pediatric patients with Guillain-Barré syndrome.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jan 2028

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2028

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Guillain-Barré syndromeAssiutECGEchocardiographyMyocardial changesPediatric

Outcome Measures

Primary Outcomes (1)

  • Prevalence of cardiac abnormalities

    Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers (troponin I or CK-MB).

    Baseline

Secondary Outcomes (5)

  • Prevalence of electrocardiographic abnormalities

    Baseline

  • Mean left ventricular ejection fraction (LVEF)

    Baseline

  • Prevalence of elevated cardiac troponin I

    Baseline

  • Prevalence of cardiac abnormalities at follow-up

    At 3 months

  • Mean left ventricular ejection fraction at follow-up

    At 3 months

Study Arms (1)

Single cohort: Pediatric patients with Guillain-Barré syndrome

Pediatric patients with confirmed Guillain-Barré syndrome who will undergo cardiac evaluation at admission and at 3-month follow-up.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients aged 1 month to 18 years with confirmed Guillain-Barré syndrome admitted to Assiut University Children's Hospital.

You may qualify if:

  • Age 1 month to 18 years
  • Confirmed diagnosis of Guillain-Barré syndrome
  • Onset of neurological symptoms within 2 weeks prior to hospital presentation
  • No pre-existing cardiac disease
  • Written informed consent from parents or legal guardians

You may not qualify if:

  • Pre-existing congenital or acquired heart disease
  • Pre-existing neuromuscular disorders or hereditary peripheral neuropathies
  • Incomplete cardiac workup (inability to perform ECG, echocardiography, and cardiac biomarker assessment)
  • Loss to follow-up before hospital discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Faisal A Ahmed, prof

    Pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

maria m monir, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Pediatrics

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

January 25, 2028

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share