MAGNET - a randomised placebo controlled trial of the use of nebulised magnesium sulphate in moderate/severe acute asthma in childhood - MAGNET

• Conditions: MAGNET is a randomised placebo(isotonic saline) controlled trial of the use of nebulised magnesium sulphate in moderate/severe acute asthma in childhood. All children (2-16 years of age) presenting to the paediatric assessment unit or the emergency unit at the University Hospital of Wales with severe asthma will be eligible for the study.

• Registration Number: EUCTR2004-003825-29-GB
• Lead Sponsor: Cardiff and Vale NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-06
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

. Severe asthma will be defined as per the BTS /SIGN guideline. For children 5 years and older severe asthma is based on one of the following criteria being met 1) oxygen saturations less than 93% while breathing room air 2) Peak expiratory flow (PEF) less than 50% best or predicted 3) Heart rate greater than 120/min 4) Respiratory rate greater than 30/min 5) Use of accessory neck muscles. For children aged 2-5 years of age, severe asthma is based on one of the following criteria being met 1) oxygen saturations less than 93% while breathing room air 2) Too breathless to talk or eat 3) Heart rate greater than 130/min 4) Respiratory rate greater than 50/min 5) Use of accessory neck muscles.
Management will be as per the guideline with inhaled (or nebulised) ß2 agonists, nebulised ipratropium and systemic corticosteroids. After 20 minutes of therapy, all children will have their oxygen saturations measured while breathing room air. All children with oxygen saturations of less than 93% will be invited into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Coexisting respiratory disease such as cystic fibrosis, chronic lung disease of prematurity, severe renal disease, severe liver disease, known to be pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified