Prevention Of Morbidity In Sickle cell disease pilot phase

ISRCTN	ISRCTN29004071
DOI	https://doi.org/10.1186/ISRCTN29004071
ClinicalTrials.gov (NCT)	NCT00415727
Protocol serial number	99-NR-31
Sponsor	Institute of Child Health (UK)
Funder	The Stroke Association (PROG 4) (UK)

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

Neuroscience Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised single blind trial
Secondary study design	Randomised controlled trial
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(s)	Change in processing speed index.
Key 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)
Completion date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Neuroscience Unit

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/09/2019: ClinicalTrials.gov number added.