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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306578
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Guillain Barre Syndrome Drug: IVIG Procedure: Plasma Exchange Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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.
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Arm Intervention/treatment
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

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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306578

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

Publications automatically indexed to this study by Identifier (NCT Number):
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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
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
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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