BronchiolitisPhase 2NCT02145520
Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
A Phase 2 study testing Magnesium Sulfate in people with Bronchiolitis and Magnesium, Abnormal Blood Level, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
In this study, investigators will compare the efficacy and safety of intravenous (IV) Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of hospitalization in admitted patients, as compared to placebo. Read more about this study
- Who is it for?
- Ages 1 month to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis, Magnesium, Abnormal Blood Level
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteQatar
- Study dates
- Oct 2012to Dec 2015
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 1-18 months of age presenting to Al Saad Pediatric Emergency Center from October 2012 to May 2015 with diagnosis of Bronchiolitis and bronchiolitis clinical severity score > 4,will be include in the study.
Who cannot join
- Prematurity (Gestational age 34 weeks or less);
- Previous history of wheezing;
- Use of steroid within 48 hours of presentation;
- CRITICALLY ill patients with one or more of the following:
- obtunded consciousness
- progressive respiratory failure requiring intensive care unit (PICU) admission;
Show all 13Show fewer
- history of apnea within 24 hours before presentation
- oxygen saturation < 85% on room air at the time of recruitment
- History of chronic lung disease;Chronic lung disease of prematurity Cystic fibrosis;
- Congenital heart disease.
- All immunodeficient children: primary or secondary
- Known hypersensitivity to magnesium sulfate.
- Known to have magnesium or calcium metabolism disturbance. (e.g.; vitamin D deficiency, hypoparathyroidism).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.
In this study, investigators will compare the efficacy and safety of intravenous (IV) Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of hospitalization in admitted patients, as compared to placebo.
Read the detailed description
- On arrival to Pediatric Emergency Center, patients will be attended by a pediatric specialist on call who will take history and perform full physical examination. Patients will be assessed for eligibility to the study based on the inclusion criteria.
- Guardians of eligible patients will be approached with the study design, objectives and risks; Patients will be included after obtaining a verbal and assigned written consent.
- A chest radiograph and Magnesium level in serum will be requested for all study patients upon recruitment.
- The observation physician will complete the data collection sheet that will include the patient's demographics, physical examination, bronchiolitis clinical severity score,oxygen saturation, chest radiograph findings and Magnesium level.
- Treatment will be delivered to enrolled patients as currently practice in PEC(Nebulized epinephrine 1:1000 1ml in 5 ml of 5% hypertonic saline, every 4 hours until discharge, for all patients and if there is history of Bronchial Asthma in mother, father or full sibling. And/or history of Eczema in the Child ,patients will start on dexamethasone 1mg/kg orally stat.(max-10 mg/dose). Then 0,6 mg/kg orally once daily starting from second day of admission for 4 days).
- All patients will be randomized to receive either Magnesium sulfate intravenous single dose over 1 hour or placebo. And it will be given in the same time with currently practice treatment
- Epinephrine nebulization can be given on PRN basis up to a maximum of every one hour, at a dose of 0.5 mg/kg (min 2.5mg/dose and max 5 mg/dose) mixed in 5 ml of 5% hypertonic saline.•
- Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge.
- Vital signs will be recorded at 0, 2, 4 hours and then every 4 hours from the administration of study medication.
- All patients will be followed up for two weeks post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.
- Conditions
- Bronchiolitis, Magnesium, Abnormal Blood Level
- Being tested
- Magnesium Sulfate, placebo
- Keywords
- bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay
placeboOther
Also called normal saline for intravenous.
use of placebo with standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate | Experimental | Magnesium sulfate. Single dose intravenous over one hour. Receives: Drug: Magnesium Sulfate |
| placebo | Placebo comparator | Treatment will be delivered to enrolled patients as currently practice in PEC (Epinephrine nebulization +5%hypertonic saline with/without dexamethasone).
•All patients will be randomized to receive either Magnesium sulfate over 1 hour or placebo.•Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate
Measured: Time to medical readiness for discharge
Secondary outcomes (1)
Improvement of bronchiolitis clinical severity score
- Need for admission to ICU during the initial visit
- Within 2 weeks after discharge:
- Need for clinical revisit
- Need for infirmary/observation unit admission
- Need for ICU admission
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid M Al-Ansai, MD, Principal investigator, HMCRafah F Sayyed, MD, Principal investigator, HMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145520
- Sponsor's protocol ID
- 12216/12
- Other IDs
- 12216/12
- Status last verified
- Mar 2015
- First submitted
- 28 Jan 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alansari K, Sayyed R, Davidson BL, Al Jawala S, Ghadier M. IV Magnesium Sulfate for Bronchiolitis: A Randomized Trial. Chest. 2017 Jul;152(1):113-119. doi: 10.1016/j.chest.2017.03.002. Epub 2017 Mar 9.
PubMed 28286262
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.
- ClinicalTrials.gov ID
- NCT02145520
- Acronym / sponsor ID
- 12216/12
- Conditions
- Bronchiolitis, Magnesium, Abnormal Blood Level
- Keywords
- bronchiolitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2014 (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.
In this study, investigators will compare the efficacy and safety of intravenous (IV) Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of hospitalization in admitted patients, as compared to placebo.
Detailed description
- On arrival to Pediatric Emergency Center, patients will be attended by a pediatric specialist on call who will take history and perform full physical examination. Patients will be assessed for eligibility to the study based on the inclusion criteria.
- Guardians of eligible patients will be approached with the study design, objectives and risks; Patients will be included after obtaining a verbal and assigned written consent.
- A chest radiograph and Magnesium level in serum will be requested for all study patients upon recruitment.
- The observation physician will complete the data collection sheet that will include the patient's demographics, physical examination, bronchiolitis clinical severity score,oxygen saturation, chest radiograph findings and Magnesium level.
- Treatment will be delivered to enrolled patients as currently practice in PEC(Nebulized epinephrine 1:1000 1ml in 5 ml of 5% hypertonic saline, every 4 hours until discharge, for all patients and if there is history of Bronchial Asthma in mother, father or full sibling. And/or history of Eczema in the Child ,patients will start on dexamethasone 1mg/kg orally stat.(max-10 mg/dose). Then 0,6 mg/kg orally once daily starting from second day of admission for 4 days).
- All patients will be randomized to receive either Magnesium sulfate intravenous single dose over 1 hour or placebo. And it will be given in the same time with currently practice treatment
- Epinephrine nebulization can be given on PRN basis up to a maximum of every one hour, at a dose of 0.5 mg/kg (min 2.5mg/dose and max 5 mg/dose) mixed in 5 ml of 5% hypertonic saline.•
- Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge.
- Vital signs will be recorded at 0, 2, 4 hours and then every 4 hours from the administration of study medication.
- All patients will be followed up for two weeks post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Experimental | Drug: Magnesium SulfateMagnesium sulfate. Single dose intravenous over one hour. |
| placebo | Placebo comparator | Other: placeboTreatment will be delivered to enrolled patients as currently practice in PEC (Epinephrine nebulization +5%hypertonic saline with/without dexamethasone). •All patients will be randomized to receive either Magnesium sulfate over 1 hour or placebo.•Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge. |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants 1-18 months of age presenting to Al Saad Pediatric Emergency Center from October 2012 to May 2015 with diagnosis of Bronchiolitis and bronchiolitis clinical severity score > 4,will be include in the study.
Key exclusion criteria (13 listed)
- Prematurity (Gestational age 34 weeks or less);
- Previous history of wheezing;
- Use of steroid within 48 hours of presentation;
- CRITICALLY ill patients with one or more of the following:
- History of chronic lung disease;Chronic lung disease of prematurity Cystic fibrosis;
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 |
|---|---|---|
| Magnesium SulfateThe use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay | Drug | Magnesium sulfate |
| placeboAlso: normal saline for intravenous.use of placebo with standard therapy | Other | placebo |
Primary outcome
Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate
Time frame: Time to medical readiness for discharge
1 secondary outcome
Improvement of bronchiolitis clinical severity score
Time frame: 2 Weeks
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 16 Aug 2016.
- Derived from this study: PubMed 28286262Alansari K, Sayyed R, Davidson BL, Al Jawala S, Ghadier M. IV Magnesium Sulfate for Bronchiolitis: A Randomized Trial. Chest. 2017 Jul;152(1):113-119. doi: 10.1016/j.chest.2017.03.002. Epub 2017 Mar 9.
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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.
Khalid M Al-Ansai, MD principal investigator
HMC
Rafah F Sayyed, MD principal investigator
HMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Sulfate in people with Bronchiolitis and Magnesium, Abnormal Blood Level, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 inclusion and 13 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 16 Aug 2016. 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 Qatar. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate (time frame: Time to medical readiness for discharge). 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 NCT02145520, which also lists 1 linked publication.
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 16 Aug 2016.