Pulmonary Epithelial Barrier and Immunological Functions at Birth and in Early Life - Key Determinants of the Development of Asthma

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The investigators want to know why some babies wheeze and some of these go on to develop asthma. The investigators are going to find out if babies who develop wheeze and asthma have abnormal airway lining cells (taken from the nose) when they are born and what happens to these cells as they get older. The study will last three years. Parents will be asked to fill in a monthly health questionnaire. The tests on the babies are all in routine clinical use: a urine sample, a blood test from a heel or finger prick, swabs from the nose and throat to look at the microbiome, and a brushing of cells from the inside of the nose. These tests will be performed at 5-10 days old, and at one and three years. Parents will be asked to fill in online monthly health questionnaire. Some babies will have the swabs repeated at 3 and 6 months, and those who wheeze in the first 3 years of life, samples during the illness and after recovery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 days
Maximum Age: 16
Healthy Volunteers: t
View:

• expectant mother or infant aged 0-10 days

• children with recurrent wheezing and other clinical atopy

• children with recurrent wheezing and no obvious wheezing triggered by aeroallergens and no clinical evidence of other atopy.

• children with no history of wheezing but with at least one clinically apparent atopic disorder

• children with no history of wheezing and with no clinical evidence of other atopic disorder

• all children will be undergoing an elective surgical procedure

• all children will have been born at term (37-42 weeks gestation)

• the anaesthetist will have deemed the child fit for elective surgery, free from a recent respiratory tract infection, stable and suitable for the research study samples to be taken.

• in the case of blind non-bronchoscopic sample suitable for endotracheal intubation or for a fibre-optic bronchoscopy if this is the chosen method of sampling

Locations
Other Locations
United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Mindy L Gore, PhD
m.gore@imperial.ac.uk
+442075946857
Time Frame
Start Date: 2017-02-20
Estimated Completion Date: 2024-09-18
Participants
Target number of participants: 1300
Treatments
1/Birth cohort
Prospective, longitudinal cohort of 1000 healthy infants. Recruited at birth and followed for 3 years. Samples to be collected at 5-10 days old, 1 and 3 years old. 100 participants with additional samples collected at 3 and 6 months of age. Approximately 300 participants to have samples collected at time of active wheezing and during convalescence.
2/mild wheezers and controls
Children under 5 years old undergoing elective general surgical procedure. Some will have mild-to-moderate wheeze while others will be non-wheezing controls
3/pre-school aged severe wheezers
50 children aged 1-6 years undergoing clinically indicated bronchoscopy due to recurrent wheezing.
4/school aged severe asthmatics
50 kids aged 6-16 undergoing clinically indicated bronchoscopy due to asthma.
Related Therapeutic Areas
Sponsors
Collaborators: Monash University, University of Aberdeen, Queen Mary University of London, University of Bristol, Queen's University, Belfast, University of Southampton, University of Edinburgh
Leads: Imperial College London

This content was sourced from clinicaltrials.gov