Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00004833
Brief 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.
Detailed Description:
PROTOCOL OUTLINE:
This is a randomized, multicenter study.
Patients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II).
Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7, 8, or 9.
Arm II patients receive serial plasmapheresis treatments. The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days.
Patients are followed at weeks 1, 2, 3, 4, 8, 12, and 24.
Completion date provided represents the completion date of the grant per OOPD records
Study:
NCT00004833
Study Brief:
Protocol Section:
NCT00004833