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Asthma in ChildrenPhase 4NCT04497766

Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma

A Phase 4 study testing Nebulized Magnesium sulfate and Intravenous magnesium sulphate in people with Asthma in Children, run by Saima Khatoon at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in… Read more about this study

Who is it for?
Ages 2 to 12 years
Conditions the study is for
Asthma in Children
What is being tested?
Nebulized Magnesium sulfate and Intravenous magnesium sulphate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 sitePakistan
Study dates
1 Oct 2019to 30 Sep 2020
Phase
Phase 4
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 2 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma as per operational definition children who are unrespoinsive to standard treatment of asthma at 60 minutes

Who cannot join

  • those with history of chronic lung disease and abnormal renal function contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children who has other comorbid illness

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • King edward medical university/mayo hospital lahore

    Lahore, Punjab Province, 56000

Other trials in Pakistan

About this study

Official title: Comparasion of Efficacy of Nebulized Magnesium Sulphate With Intravenous Magnesium Sulphate in Children With Acute Asthma

The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.

Read the detailed description

After getting informed consent from guardian,148 patients of acute moderate ro severe asthma with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will receive nebulization with magnesium sulphate and other will receive intravenous magnesium sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in either groups after 6 hours.

Being tested
Nebulized Magnesium sulfate, Intravenous magnesium sulphate
Keywords
asthma in children, intravenous magnesium sulphate, nebulized magnesium sulphate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nebulized Magnesium sulfateDrug

    Also called Nebulized MgSO4

    MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes

  • Intravenous magnesium sulphateDrug

    Also called IV MgSO4

    pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour

Study groups in NCT04497766
Study groupRoleWhat they receive
Nebulized magnesium sulphateExperimental100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer
Receives: Drug: Nebulized Magnesium sulfate
Intravenous magnesium sulphateExperimentalMagnesium sulphate according to weight will be given intravenously.
Receives: Drug: Intravenous magnesium sulphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.

    The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.

    Measured: 6 hours

Secondary outcomes (2)

  1. duration of ICU stay

    this will be measured in hours

    Measured: 72 hours/3 days

  2. duration of hospital stay

    this will be measured in hours

    Measured: 120 hours/5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start1 Oct 2019
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497766
Sponsor's protocol ID
137/RC/KEMU
Status last verified
Feb 2021
First submitted
16 Jul 2020
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be shared after publication on a reasonable request.

Publications

  • Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P; MAGNETIC study group. Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22.

    PubMed 24429155

  • Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.

    PubMed 25024668

  • Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.

    PubMed 24429154

  • Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Paediatr. 2014 Dec;103(12):1301-6. doi: 10.1111/apa.12780. Epub 2014 Oct 2.

    PubMed 25164315

  • Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.

    PubMed 23290189

  • Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.

    PubMed 25652104

  • Albuali WH. The use of intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1809-15. doi: 10.3109/14767058.2013.876620. Epub 2014 Jan 30.

    PubMed 24345031

  • Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.

    PubMed 27996280

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nebulized Magnesium sulfate and Intravenous magnesium sulphate in people with Asthma in Children, run by Saima Khatoon at 1 site in Pakistan.

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 1 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 23 Feb 2021. 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 Pakistan. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention. (time frame: 6 hours). 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 NCT04497766, which also lists 8 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 23 Feb 2021.

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