Assessment of a breath ammonia monitoring device for its potential to improve the management and care of patients with urea cycle disorders

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 94 人开始时间: 2017年11月29日最近更新: 2021年11月29日

试验速览

2019 Funder report results see attached file ISRCTN98291277_Other unpublished result_30Oct19.pdf (added 17/11/2021)

•Clinic Study: Inclusion criteria for patients with Urea Cycle Disorder and other hyper-ammonaemic conditions
•1. Aged = 5 years
•2. Diagnosis of a UCD or other hyper-ammonaemic condition
•3. Capable of providing a valid breath sample
•4. Providing a blood sample as part of their clinical care
•Clinic Study: Inclusion criteria for control patients
•1. Patients without a UCD or another hyper-ammonaemic condition attending for a routine inborn error of metabolism (IEM) hospital appointment and providing a blood sample as part of their clinical care. An additional 1-2ml whole blood is required for the measurement of blood ammonia.
•2. Aged = 5 years
•3. Capable of providing a valid breath sample
•Home Study: Inclusion criteria (patients with Urea Cycle Disorder or other hyper-ammonaemic conditions)
•1. Aged = 5 years
•2. Diagnosis of a UCD or other hyper-ammonaemic condition
•3. Capable of providing valid breath samples
•4. Family willing to help patient collect breath samples and record data

发起方

niversity Hospitals Bristol NHS Foundation Trust