Condition category
Haematological Disorders
Date applied
19/11/2006
Date assigned
12/01/2007
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Fenella Kirkham

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

99-NR-31

Study information

Scientific title

Acronym

POMS

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

22

Participant 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)

Recruitment start date

01/11/2006

Recruitment end date

31/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neuroscience Unit
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Institute of Child Health (UK)

Sponsor details

c/o Ms Emma Pendleton
Director of Research and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

University/education

Website

http://www.ich.ucl.ac.uk/ich/

Funders

Funder type

Charity

Funder name

The Stroke Association (PROG 4) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19570752

Publication citations

  1. Results

    Marshall MJ, Bucks RS, Hogan AM, Hambleton IR, Height SE, Dick MC, Kirkham FJ, Rees DC, Auto-adjusting positive airway pressure in children with sickle cell anemia: results of a phase I randomized controlled trial., Haematologica, 2009, 94, 7, 1006-1010, doi: 10.3324/haematol.2008.005215.

Additional files

Editorial Notes