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

March 1, 2011 updated by: Mansoura University Children Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Mansoura University Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Plasmapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: 21 days (average)
How many days did the mechanical ventilation continue
21 days (average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PICU stay
Time Frame: 28 days (average)
How many days did the child spend on PICU
28 days (average)
Ability to walk
Time Frame: 4 weeks from PICU discharge
Ability of the child to walk unaided at 4 weeks from PICU admission
4 weeks from PICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University Children Hospital

Investigators

  • Principal Investigator: Mohammed A El-Bayoumi, MD, FRCPCH, Head of PICU, Mansoura University Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUCH-GBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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