A randomised, double blind, double-dummy, placebo controlled trial of inhaled treatment to establish the mechanisms of prematurity-associated airway obstruction and inflammation. - RHINO: Respiratory Health Outcomes in Neonates

Cardiff University0 个研究点目标入组 7,000 人开始时间: 2019年11月13日最近更新: 2020年11月16日

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•1)Children aged 7-12 at the time of screening
•2)Born at a gestational age =34 weeks (NB. sufficient numbers of term-born participants to enroll n=100 controls will also be invited)
•3)Resident in the south Wales area whom, in the opinion of the Investigator, are possible to follow up
•4)Fully informed proxy consent from parents/guardians and assent from child where possible
•1)As part 1
•2)Preterm-born children found during part 1 to have FEV1 =85% predicted
•NB. Approximately N=100 preterm-born and N=100 term-born controls with %FEV1 >85% predicted will also be invited to Part 2 visit 1
•1)Preterm-born children found to have FEV1 =85% at baseline laboratory visit (part 2, visit 1) who participated in the treatment trial
•2)Willing to travel to the University of Sheffield Academic Unit of Radiology, Royal Hallamshire Hospital
•NB. Approximately n=20 preterm-born and n=20 term-born controls (all with normal lung function) will also be invited to Part 3
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 200
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1)Respiratory tract infection within the last three 3 weeks (will be re-invited at a later date)
•2)Congenital abnormalities
•3)In the opinion of the Investigator:
•severe cardiopulmonary defects, or
•neuromuscular disease, or
•severe neurodevelopmental impairment
•Which prohibit the possibility of compliance with the study protocol
•1)As part 1
•2)Known hypersensitivity to salmeterol and/or fluticasone
•1)Surgery of any type in the previous 2 months
•2)Previous brain surgery involving placement of clips or shunts
•3)Eye injuries resulting from metal fragments
•4)Presence of any metal implants including pacemakers
•5)Possibility to be or known to be pregnant

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