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临床试验/NCT01861470
NCT01861470已完成不适用

Reducing Painful Eye Examinations in Preterm Infants

Newcastle-upon-Tyne Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
the ability of urinary NTproBNP (normalised to creatinine) at 14 days of age and 28 days to predict severity of ROP

研究概览

简要总结

More than 8000 babies born >8 weeks early or weighing less than 1500g at birth in the United Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP). Less than 1 in 10 need treating, but to identify these all of them require eye examinations 1-2 weekly from 5 weeks. These tests are uncomfortable, upsetting for families, and cost considerable time and money.

There is now a new urine test that might help identify babies with the highest risk of developing significant ROP. This cheap test appears to predict which babies need treatment and could avoid invasive eye examination in thousands of babies. The test has so far only been used in 136 babies. It accurately predicted ROP, but 136 babies cannot change practice. We need to test more babies including in the UK. This study is designed to test >300 UK babies to see how accurately urine levels of NTproBNP predict development of ROP needing treatment.

We will also pool our data with other researchers across Europe testing the same test to identify the best 'cut'-off' value for this test. In the future babies with urine levels of this chemical lower than this cut-off level would not need invasive eye examinations.

If this test works as we hope it will many babies will avoid repeated painful eye tests, and their families will be saved the stress of watching this being done, by replacing these with a simple easy cheap pain free urine test. There will be substantial savings in health care costs that could be used to improve other aspects of care. In resource poor settings without an expert ophthalmologist babies could be screened for ROP that currently cannot be screened.

We hope to demonstrate this to be a family-friendly, achievable intervention that positively impacts on the lives of babies and families experiencing neonatal intensive care.

详细描述

See protocol

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 56 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants <1500g or <32 weeks gestation

排除标准

  • Separate ocular pathology

结局指标

主要结局

the ability of urinary NTproBNP (normalised to creatinine) at 14 days of age and 28 days to predict severity of ROP

时间窗: day 14 and day 28

次要结局

  • Receiver operator characteristics curve, sensitivity, specificity, positive and negative predictive values.(day 14 and day 28)

研究者

发起方
Newcastle-upon-Tyne Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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