NCT02112305

Brief Summary

The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

April 4, 2014

Last Update Submit

November 15, 2014

Conditions

Keywords

Magnesium sulphate nebulized

Outcome Measures

Primary Outcomes (1)

  • Asthma severity score

    60 minute

Secondary Outcomes (1)

  • Length of stay in the hospital

    within 2 weeks

Study Arms (2)

isotonic magnesium sulphate

EXPERIMENTAL

2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval

Drug: isotonic magnesium sulphate

50% magnesium sulphate

ACTIVE COMPARATOR

magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Drug: 50% magnesium sulphate

Interventions

2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval

Also known as: magnesium sulfate
isotonic magnesium sulphate

magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Also known as: magnesium sulfate
50% magnesium sulphate

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy

You may not qualify if:

  • chronic lung disease
  • history of adverse reaction form magnesium sulphate
  • life threatening condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Sirikit National Institute of Child Health

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Tassalapa Daengsuwan, Pediatrician

    Queen Sirikit National Institute of Child Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 11, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations