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

This study has been completed.
Information provided by:
Mansoura University Children Hospital Identifier:
First received: March 1, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.

Condition Intervention
Guillain Barre Syndrome Drug: IVIG Procedure: Plasma Exchange

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.

Resource links provided by NLM:

Further study details as provided by Mansoura University Children Hospital:

Primary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: 21 days (average) ]
    How many days did the mechanical ventilation continue

Secondary Outcome Measures:
  • PICU stay [ Time Frame: 28 days (average) ]
    How many days did the child spend on PICU

  • Ability to walk [ Time Frame: 4 weeks from PICU discharge ]
    Ability of the child to walk unaided at 4 weeks from PICU admission

Enrollment: 41
Study Start Date: January 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IVIG group
20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
Drug: IVIG
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

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.


Ages Eligible for Study:   1 Month to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01306578

Mansoura University Children Hospital
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University Children Hospital
Principal Investigator: Mohammed A El-Bayoumi, MD, FRCPCH Head of PICU, Mansoura University Children Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Mohammed El-Bayoumi, MD, FRCPCH, Head of PICU - Mansoura University Children Hospital Identifier: NCT01306578     History of Changes
Other Study ID Numbers: MUCH-GBS
Study First Received: March 1, 2011
Last Updated: March 1, 2011

Keywords provided by Mansoura University Children Hospital:
Guillain Barre syndrome
Plasma exchange

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Pathologic Processes
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017