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

Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01306578

Enrollment

Registered

2011-03-02

Start date

2007-01-31

Completion date

2010-02-28

Last updated

2011-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guillain Barre Syndrome

Keywords

Guillain Barre syndrome, IVIG, Plasma exchange

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.

Interventions

DRUGIVIG

Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days

PROCEDUREPlasma Exchange

Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Duration of mechanical ventilation	21 days (average)	How many days did the mechanical ventilation continue

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026