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

Guillain Barre Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306578
• Other study ID #: MUCH-GBS
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: March 1, 2011
• Start date: January 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2011
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Guillain Barre Syndrome
• Guillain-Barre Syndrome
• Syndrome

Intervention

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

Procedure:
• Plasma Exchange
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	How many days did the mechanical ventilation continue	21 days (average)	No
Secondary	PICU stay	How many days did the child spend on PICU	28 days (average)	No
Secondary	Ability to walk	Ability of the child to walk unaided at 4 weeks from PICU admission	4 weeks from PICU discharge	No