Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

Sickle Cell Anaemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00415727
• Other study ID #: 99NR31
• Status: Recruiting
• Phase: Phase 2
• First received: December 22, 2006
• Last updated: December 23, 2006
• Start date: November 2006

Study information

• Verified date: December 2006
• Source: Institute of Child Health
• Contact: Fenella Kirkham, Dr
• Email: f.kirkham[@]ich.ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Age >4 years.

2. 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.

3. Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anaemia

Intervention

Device:
• auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation

Locations

Country	Name	City	State
United Kingdom	Kings College hospital	London
United Kingdom	Neuroscience Unit, Institute of Child Health	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in processing speed index
Secondary	Frequency of pain measured via SMS and pain diary
Secondary	Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count
Secondary	Change in Blood pressure
Secondary	Number of omissions on Conners Continuous Performance Test
Secondary	Change in Chervin sleep Questionnaire
Secondary	Change in Behaviour Rating Inventory of Executive Function (BRIEF)
Secondary	Change in number of abnormalities (Adams’ criteria) on TCD