RHINO: Respiratory Health Outcomes in Neonates
Research type
Research Study
Full title
A randomised, double blind, placebo controlled trial of inhaled treatment to establish the mechanisms of prematurity-associated airway obstruction and inflammation.
IRAS ID
185815
Contact name
Sailesh Kotecha
Contact email
Sponsor organisation
Cardiff University
Eudract number
2015-003712-20
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
We know that children who are born prematurely have breathing problems like wheezing (“whistling in their chest”) or shortness of breath but we do not know why. RHINO is a trial to investigate the reasons for increased respiratory symptoms and reduced lung function in children who were born prematurely, and to find out if these respond to treatment.
Firstly we shall conduct a follow-up to our recent study (RANOPS MREC12/WA/0155) by sending a respiratory and neurological health outcome questionnaire to 4200 families of prematurely born children and 2800 term born controls.
We shall then invite 1000 families of children aged 7-12, born prematurely (at 34 weeks gestation or less) to take part in a home screening visit in order to identify 200 who have reduced lung function (part 1).
These children will be invited to attend 2 clinic visits for extensive lung function testing; the two visits will be separated by a 12-week treatment trial of inhaled medicines commonly used to treat asthma.
We shall compare the results of tests before and after the treatment trial to establish if the medicines work (Part 2).In order to generalise our results we will invite 50 children born at term (37 weeks gestation and over) with normal lung function, and 50 children born prematurely with normal lung function, to participate in each part of the trial as comparison groups.
To understand more about the reasons why the medicines work (or did not), 60/200 participants in the treatment trial and 40 controls (20 term and 20 preterm with normal lung function) will be invited to undergo a specialised MRI scan to investigate the structure of the lungs and the way gases move within them (Part 3).
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0289
Date of REC Opinion
12 Nov 2015
REC opinion
Favourable Opinion