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| A randomised, placebo controlled study of nebulised magnesium in acute severe asthma in children |
| Source of record | UK Trials |
| ISRCTN | ISRCTN81456894 |
| Date ISRCTN assigned | 15/11/2007 |
| Local reference number(s) | HTA 02/503/10 |
| Public title | A randomised, placebo controlled study of nebulised magnesium in acute severe asthma in children |
| Scientific title | |
| Acronym | MAGNETIC |
| Disease/condition/study domain | Severe exacerbation of asthma |
| Study hypothesis | Does nebulised magnesium used as an adjunct to nebulised salbutamol and ipratropium bromide for one hour in children with severe asthma result in a clinical improvement when compared to nebulsied salbutamol, ipratropium bromide and placebo? |
| Design/methodology | A multicentre, randomised, placebo controlled study of nebulised magnesium in acute severe asthma in children |
| Research ethics review | Plan to submit to North West MREC in December 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | For children 6 years and older severe asthma is based on at least one of the following criteria being met: 1. Oxygen saturations less than 92% while breathing room air 2. Too breathless to talk 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 at least one of the following criteria being met: 1. Oxygen saturations less than 92% while breathing room air 2. Too breathless to talk 3. Heart rate greater than 130/min 4. Respiratory rate greater than 50/min 5. Use of accessory neck muscles |
| Participants - exclusion criteria | 1. Coexisting respiratory disease such as cystic fibrosis, chronic lung disease of prematurity 2. Severe renal disease 3. Severe liver disease 4. Known to be pregnant 5. Known to have had a reaction to magnesium previously 6. Parents who are unable to give informed consent 7. Previously randomised into MAGNETIC trial 8. Patients who present with life threatening symptoms 9. Previously involved with a trial of a medicinal product in the three months preceding screening |
| Patient information material | |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 01/03/2010 |
| Status of trial | Ongoing |
| Target number of participants | 500 |
| Interventions | Children aged 2 - 5 years will be randomised to receive nebulised salbutamol 2.5 mg and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic magnesium sulphate (250 mmol/L, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at twenty-minute intervals. Children 6 years and over will receive 5 mg of nebulised salbutamol. Total duration of follow-up is one month. |
| Primary outcome measure(s) | The Yung Asthma Severity Score (ASS) after 60 minutes of treatment. |
| Secondary outcome measure(s) | Clinical (during hospitalisation): 1. ¿Stepping down¿ of treatment at one hour i.e. changed to having hourly treatment after the initial three, twenty-minute nebulisers 2. Number and frequency of additional salbutamol 3. Length of stay in hospital 4. Requirement for intravenous bronchodilator treatment 5. Intubation and/or admission to a Paediatric Intensive Care Unit (PICU) Patient outcomes at follow-up (1 month): 1. Paediatric Quality of Life Inventory (PedsQL™) asthma module parental report for all children and self-completion if aged over 5 years, European Quality of Life questionnaire (EQ-5D) 2. Time off school/nursery 3. Health care resource usage (e.g. General Practitioner [GP] visits, additional prescribing) Parent outcomes at follow-up (1 month): 1. Time off work (related to child¿s illness) |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Cardiff University (UK) |
| Sponsor details | Newport Road Cardiff United Kingdom CF24 0DE |
| Sponsor telephone | +44 (0)29 2087 9274 |
| Sponsor fax | +44 (0)29 2087 9280 |
| Sponsor email | davieskp2@cardiff.ac.uk |
| Sponsor website | http://www.cf.ac.uk |
| Contact name | Dr Colin Powell |
| Contact details | Department of Paediatrics University Hospital of Wales Heath Park Cardiff United Kingdom CF14 4XW |
| Contact telephone | +44 (0)29 2074 7747 |
| Contact fax | +44 (0)29 2074 4822 |
| Contact email | colin.powell@cardiffandvale.wales.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN81456894 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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