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.
1 other identifier
interventional
41
1 country
1
Brief Summary
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedMarch 2, 2011
February 1, 2011
2.9 years
March 1, 2011
March 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of mechanical ventilation
How many days did the mechanical ventilation continue
21 days (average)
Secondary Outcomes (2)
PICU stay
28 days (average)
Ability to walk
4 weeks from PICU discharge
Study Arms (2)
IVIG group
ACTIVE COMPARATOR20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
Plasma Exchange
ACTIVE COMPARATOR21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
Interventions
Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
Eligibility Criteria
You may qualify if:
- Age: children from 1 month - 18 years old
- Clinical diagnosis of Guillain Barre syndrome
- Requirement of mechanical ventilation
You may not qualify if:
- Need for mechanical ventilation beyond 14 days from disease onset
- Child receiving IVIG or PE prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Related Publications (2)
Saleh M, Boukhdoud M, Boukhdoud H, Al Zein M, Salameh P. Landscape of Guillain-Barre Syndrome Interventional Clinical Trials. J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441.
PMID: 36809199DERIVEDEl-Bayoumi MA, El-Refaey AM, Abdelkader AM, El-Assmy MM, Alwakeel AA, El-Tahan HM. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barre syndrome: a randomized study. Crit Care. 2011 Jul 11;15(4):R164. doi: 10.1186/cc10305.
PMID: 21745374DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammed A El-Bayoumi, MD, FRCPCH
Head of PICU, Mansoura University Children Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 2, 2011
Study Start
January 1, 2007
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
March 2, 2011
Record last verified: 2011-02