Sickle Cell AnaemiaPhase 2NCT00415727
Prevention Of Morbidity In Sickle Cell Disease Pilot Phase
A Phase 2 study testing auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation in people with Sickle Cell Anaemia, run by Institute of Child Health at 2 sites in United Kingdom.
Trial summary
The hypothesis is that 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 and/or oxygen supplementation. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Sickle Cell Anaemia
- What is being tested?
- auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Child
Who may be able to join
- Age >4 years.
- Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study.
- Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Fenella Kirkham, Dr contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Neuroscience Unit, Institute of Child Health
London, WC1N 1EH
Fenella Kirkham, Dr, f.kirkham@ich.ucl.ac.uk
Fenella Kirkham, Dr
- Recruiting
Kings College hospital
London, WC2R 2LS
David Rees, Dr, david.rees@kcl.ac.uk
David Rees, Dr
About this study
The hypothesis is that 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 and/or oxygen supplementation.
Read the detailed description
Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not >94% after 2 weeks of autoCPAP
- Conditions
- Sickle Cell Anaemia
- Being tested
- auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in processing speed index
Secondary outcomes (7)
Frequency of pain measured via SMS and pain diary
Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count
Change in Blood pressure
Number of omissions on Conners Continuous Performance Test
Change in Chervin sleep Questionnaire
Change in Behaviour Rating Inventory of Executive Function (BRIEF)
Change in number of abnormalities (Adams' criteria) on TCD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Fenella Kirkham, Dr, Principal investigator, Institute Of Child Health and Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415727
- Sponsor's protocol ID
- 99NR31
- Status last verified
- Dec 2006
- First submitted
- 22 Dec 2006
- Last updated
- 25 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Of Morbidity In Sickle Cell Disease Pilot Phase
- ClinicalTrials.gov ID
- NCT00415727
- Acronym / sponsor ID
- 99NR31
- Conditions
- Sickle Cell Anaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Nov 2006
- First posted
- 25 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that 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 and/or oxygen supplementation.
Detailed description
Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not >94% after 2 weeks of autoCPAP
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age >4 years.
- Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study.
- Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation | Device | – |
Primary outcome
Change in processing speed index
7 secondary outcomes
Frequency of pain measured via SMS and pain diary
Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count
Change in Blood pressure
Number of omissions on Conners Continuous Performance Test
Change in Chervin sleep Questionnaire
Change in Behaviour Rating Inventory of Executive Function (BRIEF)
Change in number of abnormalities (Adams' criteria) on TCD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fenella Kirkham, Dr contact
Fenella Kirkham, Dr principal investigator
Institute Of Child Health and Great Ormond Street Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation in people with Sickle Cell Anaemia, run by Institute of Child Health at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fenella Kirkham, Dr (f.kirkham@ich.ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in processing speed index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2006.