|
Welcome
|
|
21 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
|
Prevention Of Morbidity In Sickle cell disease pilot phase
|
| ISRCTN | ISRCTN29004071 |
| ClinicalTrials.gov identifier | |
| Public title |
Prevention Of Morbidity In Sickle cell disease pilot phase
|
| Scientific title | |
| Acronym | POMS |
| Serial number at source | 99-NR-31 |
| Study hypothesis | In sickle cell anaemia, nocturnal oxyhaemoglobin desaturation is associated with low processing speed index, and this morbidity can be reduced with overnight auto Continuous Positive Airways Pressure (CPAP) and/or oxygen supplementation. |
| Lay summary | |
| Ethics approval | St Marys Hospital Research Ethics Committee has approved the pilot phase of this study on the 25th September 2006 (ref: 06/Q0403/133). |
| Study design | Randomised single blind trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Sickle cell anaemia |
| Participants - inclusion criteria |
1. Age more than four years old
2. Informed consent with assent in accordance with UK ethical committee (Central Office for Research Ethics Committees [COREC]) system must be signed by the patient's parent or legally authorised guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study 3. Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis |
| Participants - exclusion criteria |
1. Existing respiratory failure
2. Decompensated cardiac failure 3. History of severe epistaxis 4. Trans-sphenoidal surgery, or trauma that could have left a cranio-nasopharyngeal fistula 5. Perforated ear drum 6. Bullous lung disease 7. Bypassed upper airway 8. Pneumothorax 9. Pathologically low blood pressure 10. Cerebral Spinal Fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus 11. Patients on chronic regular blood transfusion 12. Patient who received treatment with anti-sickling drugs or hydroxyurea within three months 13. Patient with other neurological problems, such as neurofibromatosis, lead poisoning, or tuberous sclerosis 14. Pregnancy 15. Sinus or middle ear infection (temporary) |
| Anticipated start date | 01/11/2006 |
| Anticipated end date | 31/10/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 22 |
| Interventions | Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not more than 94% after two weeks of autoCPAP versus no treatment. |
| Primary outcome measure(s) | Change in processing speed index. |
| Secondary outcome measure(s) |
1. Frequency of pain measured via SMS and pain diary
2. Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count 3. Change in blood pressure 4. Number of omissions on Conners Continuous Performance Test 5. Change in Chervin sleep questionnaire 6. Change in Behaviour Rating Inventory of Executive Function (BRIEF) 7. Change in number of abnormalities (Adam's criteria) on Trans Cranial Doppler (TCD) |
| Sources of funding | The Stroke Association (PROG 4) (UK) |
| Trial website | http://www.stroke.org.uk/research/funded_research/research_projects_programme_grants/research_region/london/preventing.html |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19570752 |
| Contact name | Prof Fenella Kirkham |
| Address |
Neuroscience Unit
Institute of Child Health 30 Guilford Street |
| City/town | London |
| Zip/Postcode | WC1N 1EH |
| Country | United Kingdom |
| Sponsor | Institute of Child Health (UK) |
| Address |
c/o Ms Emma Pendleton
Director of Research and Development 30 Guilford Street |
| City/town | London |
| Zip/Postcode | WC1N 1EH |
| Country | United Kingdom |
| Sponsor website: | http://www.ich.ucl.ac.uk/ich/ |
| Date applied | 19/11/2006 |
| Last edited | 28/04/2011 |
| Date ISRCTN assigned | 12/01/2007 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|