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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

March 1, 2011
March 1, 2011
January 2007
December 2009   (final data collection date for primary outcome measure)
Duration of mechanical ventilation [ Time Frame: 21 days (average) ] [ Designated as safety issue: No ]
How many days did the mechanical ventilation continue
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
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.

Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Guillain Barre Syndrome
  • Drug: IVIG
    Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
    Other Name: Sandglobin
  • Procedure: Plasma Exchange
    Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
    Other Name: Plasmapheresis
  • Active Comparator: IVIG group
    20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
    Intervention: Drug: IVIG
  • Active Comparator: Plasma Exchange
    21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
    Intervention: Procedure: Plasma Exchange
El-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 Barré syndrome: a randomized study. Crit Care. 2011 Jul 11;15(4):R164. doi: 10.1186/cc10305.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
1 Month to 18 Months
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01306578
MUCH-GBS
Yes
Dr. Mohammed El-Bayoumi, MD, FRCPCH, Head of PICU - Mansoura University Children Hospital
Mansoura University Children Hospital
Not Provided
Principal Investigator: Mohammed A El-Bayoumi, MD, FRCPCH Head of PICU, Mansoura University Children Hospital
Mansoura University Children Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP