Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

Institute of Child Health22 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Sickle Cell Anaemia

Interventions

auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementationDEVICE

Eligibility

Sex: ALLMin age: 4 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (2)

Neuroscience Unit, Institute of Child Health

London, United Kingdom

RECRUITING

Kings College hospital

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Change in processing speed index

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

Central Contacts

Fenella Kirkham, Dr

CONTACT

f.kirkham@ich.ucl.ac.uk

Data from ClinicalTrials.gov

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