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

Mansoura University Children Hospital

Status: Completed

Conditions: Guillain Barre Syndrome

Treatments: Procedure: Plasma Exchange; Drug: IVIG

Study type: Interventional

Funder types: Other

Identifiers

NCT01306578

MUCH-GBS

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 1 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

IVIG group

Active Comparator group

Description:

20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day

Treatment:

Drug: IVIG

Plasma Exchange

Active Comparator group

Description:

21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days

Treatment:

Procedure: Plasma Exchange