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Completed

NCT Number: NCT01306578

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

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

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Key information

Conditions

Guillain Barre Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

1 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVIG

Drug

Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days

Other names: Sandglobin

Plasma Exchange

Procedure

Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days

Other names: Plasmapheresis

Primary outcomes

  1. Duration of mechanical ventilation

    Time frame: 21 days (average)

    How many days did the mechanical ventilation continue

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 2, 2011
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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