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Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00415727
Enrollment
22
Registered
2006-12-25
Start date
2006-11-30
Completion date
Unknown
Last updated
2006-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anaemia

Brief 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.

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

Interventions

DEVICEauto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation

Sponsors

Institute of Child Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years

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.

Design outcomes

Primary

MeasureTime frame
Change in processing speed index

Secondary

MeasureTime frame
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
Frequency of pain measured via SMS and pain diary
Change in Behaviour Rating Inventory of Executive Function (BRIEF)
Change in number of abnormalities (Adams' criteria) on TCD
Change in Chervin sleep Questionnaire

Countries

United Kingdom

Contacts

Primary ContactFenella Kirkham, Dr
f.kirkham@ich.ucl.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026