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LIMBuS

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Other

Trial status

Open to recruitment

Participating Centres
Full title

Longitudinal Infant Multi-Breath washout Study (LIMBuS)

Lung clearance index (LCI) measure by multi-breath washout (MBW) has been shown to be sensitive and a non-invasive way of picking up early airways disease in infants with cystic fibrosis (CF). Abnormal measurements at a young age have been shown to track into later life and could identify children who need more aggressive treatment early. Currently there is a lack of data and suitable ways of performing this in multiple, non-specialised centres. This is a multi-centre longitudinal observational study of this measurement in children under 3 years of age with CF with a healthy control group and a disease comparison group of babies who are born early. A novel method for MBW in infants will be used which has been developed and assessed in a pilot study prior to this. We aim to show that LCI can be reliably measured across multiple centres using this method with high rates of success and that the measurements are repeatable in the short term (2-3 months). Any changes in this measurement in the CF infants and children will also be shown over 12-18 months. All parents will be consented prior to taking part and the children will be sedated as per local protocol at lower doses than usual. The CF children will be seen after recruitment, 2-3 months and 12-18 months later. The babies will be seen prior to discharge from the neonatal unit and 12 months later. The healthy children will be seen opportunistically when sedated for MRI scans in radiology and measurements taken whilst still asleep.

Trial Reference Number

107844

Trial type

Non-medication

Intervention
the name of the treatment or therapy being researched

Lung clearance index measurement via multi-breath washout.

Recruitment target
the number of participants who need to be recruited for the trial in the UK

73

Last edited date

02 July 2018

CF sponsor

University of Manchester

CF sponsor type

Academic

Who can take part?

Top inclusion criteria
  • 0 - 3 years old.
  • No respiratory infections or courses of antibiotics in the 2 weeks prior to the study visit
Top exclusion criteria
  • Other neuromuscular, skeletal, metabolic or other condition that may impact on ventilation.
  • No apnoea or upper airway disorders which will contraindicate sedation.

CF centres running this trial

Recruiting

Alder Hey Children's Hospital

Address

Alder Hey Hospital Eaton Road West Derby Liverpool Merseyside L12 2AP

Recruitment starts

October 2018

Recruitment ends

March 2020

Contact

Thursfield, Rebecca

Get in touch

Recruiting

Royal Manchester Childrens Hospital - Central Manchester University Hospitals NHS Foundation Trust

Address

Oxford Road Manchester M13 9WL M27 4HA

Recruitment ends

March 2020

Contact

,

Get in touch