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Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG group | Active Comparator | 20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day |
|
| Plasma Exchange | Active Comparator | 21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | How many days did the mechanical ventilation continue | 21 days (average) |
| Measure | Description | Time Frame |
|---|---|---|
| PICU stay | How many days did the child spend on PICU | 28 days (average) |
| Ability to walk | Ability of the child to walk unaided at 4 weeks from PICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed A El-Bayoumi, MD, FRCPCH | Head of PICU, Mansoura University Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Children Hospital | Al Mansurah | Dakahlia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36809199 | Derived | Saleh M, Boukhdoud M, Boukhdoud H, Al Zein M, Salameh P. Landscape of Guillain-Barre Syndrome Interventional Clinical Trials. J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441. | |
| 21745374 | Derived | El-Bayoumi MA, El-Refaey AM, Abdelkader AM, El-Assmy MM, Alwakeel AA, El-Tahan HM. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barre syndrome: a randomized study. Crit Care. 2011 Jul 11;15(4):R164. doi: 10.1186/cc10305. |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D010951 | Plasma Exchange |
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Plasma Exchange | Procedure | Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days |
|
|
| 4 weeks from PICU discharge |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |