Overview

Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

Status:
Terminated

Trial end date:
2002-11-01

Target enrollment:
0

Participant gender:
All

Summary

OBJECTIVES: I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome. II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Emory University

Treatments:

Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or
reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure
sensory neuropathy; No prior history of GBS

Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable
to walk 5 meters without assistance); Must not have improvement of one or more disability
grades prior to randomization in this study

No paresthesias, numbness, or weakness that began more than 14 days before randomization in
this study

No CNS involvement

--Prior/Concurrent Therapy--

Biologic therapy: No prior treatment with plasmapheresis or infusion of human
immunoglobulin (IVIg)

Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for
concurrent medical conditions, e.g., asthma)

Radiotherapy: Not specified

Surgery: Not specified

Other: No concurrent mechanical ventilation

--Patient Characteristics--

Age: Under 18 but with at least 3 months of independent walking

Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3

Hepatic: No liver failure

Renal: No kidney failure

Neurological: No other major neurologic diseases, other neuromuscular disorders, or
cerebral palsy

Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled
infection; No known IgA hypersensitivity; No other preexisting disease that would interfere
with assessment of disability grades; No other causes of acquired weakness (e.g.,
poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant