Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)

Not Applicable

Completed

• Conditions: Guillain Barre Syndrome
• Interventions: Drug: IVIG; Procedure: Plasma Exchange

• Registration Number: NCT01306578
• Lead Sponsor: Mansoura University Children Hospital

Brief Summary

Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.

Detailed Description

Children with Guillain Barre syndrome (GBS) admitted to PICU at Mansoura University Children Hospital, Mansoura, Egypt with the need for mechanical ventilation were prospectively enrolled in the study.

Cases were diagnosed according to clinical criteria. The decisions to initiate, wean and terminate mechanical ventilation were made independently by the attending consultant in accordance with the unit guidelines.

Outcome variables measured were duration of mechanical ventilation, length of PICU stay and ability to walk unaided 4 weeks after PICU discharge.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2011-02
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Study First Posted: 2011-03-02
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Age: children from 1 month - 18 years old
• Clinical diagnosis of Guillain Barre syndrome
• Requirement of mechanical ventilation

Exclusion Criteria

• Need for mechanical ventilation beyond 14 days from disease onset
• Child receiving IVIG or PE prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVIG group	IVIG	20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
Plasma Exchange	Plasma Exchange	21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	21 days (average)	How many days did the mechanical ventilation continue

Secondary Outcome Measures

Name	Time	Method
PICU stay	28 days (average)	How many days did the child spend on PICU
Ability to walk	4 weeks from PICU discharge	Ability of the child to walk unaided at 4 weeks from PICU admission

Trial Locations

Locations (1)

Mansoura University Children Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt