Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.|
- Duration of mechanical ventilation [ Time Frame: 21 days (average) ] [ Designated as safety issue: No ]How many days did the mechanical ventilation continue
- PICU stay [ Time Frame: 28 days (average) ] [ Designated as safety issue: No ]How many days did the child spend on PICU
- Ability to walk [ Time Frame: 4 weeks from PICU discharge ] [ Designated as safety issue: No ]Ability of the child to walk unaided at 4 weeks from PICU admission
|Study Start Date:||January 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: IVIG group
20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
Other Name: Sandglobin
Active Comparator: Plasma Exchange
21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
Procedure: Plasma Exchange
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
Other Name: Plasmapheresis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306578
|Mansoura University Children Hospital|
|Mansoura, Dakahlia, Egypt|
|Principal Investigator:||Mohammed A El-Bayoumi, MD, FRCPCH||Head of PICU, Mansoura University Children Hospital|