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.
Conditions
Interventions
Product Name: Magnesium Sulphate sterile solution
Product Code: N/A
Pharmaceutical Form: Nebuliser solution
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placeb
Sponsors
Cardiff and Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Coexisting respiratory disease such as cystic fibrosis, chronic lung disease of prematurity, severe renal disease, severe liver disease, known to be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The principal outcome measure will be the mean slope of the improvement of the Asthma severity score (ASS)[Conway]. The score has been validated as a measure of asthma severity in children, has been demonstrated to be re-produceable and reliable [Bishop] with good inter-observer agreement and correlates well with oxygen saturations and FEV1 [Yung]. Additional measures will include number and frequency of additional salbutamol, PEF (if old enough to perform reliably) and length of stay in hospital. Clinical assessment will be performed at entry and at 20 minutes (randomisation), 40, 60, 80, 120, 180 and 240 minutes;Main Objective: 1) To determine the number of children presenting with poorly responsive asthma to a large University teaching Hospital 2) To determine wether nebulised magnesium sulphate has any benefit when added to nebulised salbutamol and ipratropium in this population;Secondary Objective: MAGNET will act as a pilot study to guide the design of a larger multicentre study. | — |
Countries
United Kingdom
Outcome results
None listed