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

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

Detailed Description
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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.

Official Title
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Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.

Conditions
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Guillain Barre Syndrome

Intervention / Treatment
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* Drug: IVIG
* Procedure: Plasma Exchange


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IVIG group<br>20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day | Drug: IVIG<br>* Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days<br>* Other names: Sandglobin;|
| Active Comparator: Plasma Exchange<br>21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days | Procedure: Plasma Exchange<br>* Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days<br>* Other names: Plasmapheresis;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guillain Barre syndrome, IVIG, Plasma exchange