Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

Institute of Child Health4 个研究点分布在 1 个国家目标入组 22 人开始时间: 2006年11月1日最近更新: 2006年12月25日

适应症

试验速览

阶段: 2 期
发起方: Institute of Child Health
入组人数: 22
试验地点: 4
主要终点: Change in processing speed index

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not >94% after 2 weeks of autoCPAP

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
盲法: Single

入排标准

年龄范围: 4 Years 至 16 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

未提供

结局指标

主要结局

Change in processing speed index

次要结局

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

研究者

发起方

Institute of Child Health

申办方类型

Other

研究点 (4)

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