Guillain Barre SyndromeNCT01306578
Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
A study testing IVIG and Plasma Exchange in people with Guillain Barre Syndrome, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial summary
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Guillain Barre Syndrome
- What is being tested?
- IVIG and Plasma Exchange
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: children from 1 month - 18 years old
- Clinical diagnosis of Guillain Barre syndrome
- Requirement of mechanical ventilation
Who cannot join
- Need for mechanical ventilation beyond 14 days from disease onset
- Child receiving IVIG or PE prior to enrollment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate
About this study
Official title: Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
Read the detailed 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.
- Conditions
- Guillain Barre Syndrome
- Being tested
- IVIG, Plasma Exchange
- Keywords
- Guillain Barre syndrome, IVIG, Plasma exchange
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Also called Sandglobin
Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
Plasma ExchangeProcedure or surgery
Also called Plasmapheresis
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| IVIG group | Active comparator | 20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day Receives: Drug: IVIG |
| Plasma Exchange | Active comparator | 21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days Receives: Procedure: Plasma Exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
How many days did the mechanical ventilation continue
Measured: 21 days (average)
Secondary outcomes (2)
PICU stay
How many days did the child spend on PICU
Measured: 28 days (average)
Ability to walk
Ability of the child to walk unaided at 4 weeks from PICU admission
Measured: 4 weeks from PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Guillain Barre SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mohammed A El-Bayoumi, MD, FRCPCH, Principal investigator, Head of PICU, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306578
- Sponsor's protocol ID
- MUCH-GBS
- Status last verified
- Feb 2011
- First submitted
- 1 Mar 2011
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36809199El-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.
PubMed 21745374
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.
- ClinicalTrials.gov ID
- NCT01306578
- Acronym / sponsor ID
- MUCH-GBS
- Conditions
- Guillain Barre Syndrome
- Keywords
- Guillain Barre syndrome, IVIG, Plasma exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG group | Active comparator | Drug: IVIG20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day |
| Plasma Exchange | Active comparator | Procedure: Plasma Exchange21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: children from 1 month - 18 years old
- Clinical diagnosis of Guillain Barre syndrome
- Requirement of mechanical ventilation
Key exclusion criteria (2 listed)
- Need for mechanical ventilation beyond 14 days from disease onset
- Child receiving IVIG or PE prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIGAlso: SandglobinIntravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days | Drug | IVIG group |
| Plasma ExchangeAlso: PlasmapheresisFive sessions of plasma exchange, single plasma volume each, for 5 consecutive days | Procedure or surgery | Plasma Exchange |
Primary outcome
Duration of mechanical ventilation
Time frame: 21 days (average)
How many days did the mechanical ventilation continue
2 secondary outcomes
PICU stay
Time frame: 28 days (average)
Ability to walk
Time frame: 4 weeks from PICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
- Derived from this study: PubMed 36809199Saleh 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.
- Derived from this study: PubMed 21745374El-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A El-Bayoumi, MD, FRCPCH principal investigator
Head of PICU, Mansoura University Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVIG and Plasma Exchange in people with Guillain Barre Syndrome, run by Mansoura University Children Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: 21 days (average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01306578, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.