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Trial record 3 of 20 for:    Guillain-Barré Syndrome
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Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)

This study has been completed.
Sponsor:
Information provided by:
Mansoura University Children Hospital
ClinicalTrials.gov Identifier:
NCT01306578
First received: March 1, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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: 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:

U.S. FDA Resources

Further study details as provided by Mansoura University Children Hospital:

Primary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: 21 days (average) ] [ Designated as safety issue: No ]
    How many days did the mechanical ventilation continue


Secondary Outcome Measures:
  • 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


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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306578

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

No publications provided by Mansoura University Children Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Mohammed El-Bayoumi, MD, FRCPCH, Head of PICU - Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT01306578     History of Changes
Other Study ID Numbers: MUCH-GBS
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
 Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013