Prevention Of Morbidity In Sickle cell disease pilot phase
| ISRCTN | ISRCTN29004071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29004071 |
| ClinicalTrials.gov number | NCT00415727 |
| Secondary identifying numbers | 99-NR-31 |
- Submission date
- 19/11/2006
- Registration date
- 12/01/2007
- Last edited
- 10/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Fenella Kirkham
Scientific
Scientific
Neuroscience Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
Study information
| Study design | Randomised single blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prevention Of Morbidity In Sickle cell disease pilot phase |
| Study acronym | POMS |
| Study objectives | 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. |
| Ethics approval(s) | St Marys Hospital Research Ethics Committee has approved the pilot phase of this study on the 25th September 2006 (ref: 06/Q0403/133). |
| Health condition(s) or problem(s) studied | Sickle cell anaemia |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Change in processing speed index. |
| Secondary outcome measures | 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) |
| Overall study start date | 01/11/2006 |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 22 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 31/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Neuroscience Unit
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
Institute of Child Health (UK)
University/education
University/education
c/o Ms Emma Pendleton
Director of Research and Development
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Website | http://www.ich.ucl.ac.uk/ich/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
The Stroke Association (PROG 4) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No |
Editorial Notes
10/09/2019: ClinicalTrials.gov number added.
