Understanding why some babies develop asthma
Pulmonary Epithelial Barrier and Immunological Functions at Birth and in Early Life - Key Determinants of the Development of Asthma
Imperial College London · NCT04063631
This study looks at why some babies start wheezing and develop asthma by tracking their health and testing their cells over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 5 Days to 16 Years |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT04063631 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the reasons behind wheezing in infants and the subsequent development of asthma. Researchers will analyze airway lining cells from newborns and track their changes over three years, using routine clinical tests such as urine samples, blood tests, and microbiome swabs. Parents will complete monthly health questionnaires to provide ongoing health data about their children. The goal is to identify abnormal epithelial function at birth and its progression, which may help in developing future asthma prevention strategies.
Who should consider this trial
Good fit: Ideal candidates include expectant mothers or infants aged 0-10 days, particularly those with a history of wheezing or atopic disorders.
Not a fit: Patients who are pre-term infants or those with no history of wheezing or atopic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification of infants at risk for asthma and inform preventive strategies.
How similar studies have performed: While similar studies have explored asthma development, this specific approach focusing on newborn epithelial function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * pre-term infants (\<37 weeks gestation) * twins or other multiples * maternal group B streptococcus on high vaginal swab in the present pregnancy * need for CPAP or ventilatory support in the neonatal period * infants with major concurrent health problems, e.g. congenital heart disease, cystic fibrosis, those requiring special feeding regimens on account of prematurity or illness * infants who will not be available to assess acutely if they develop wheeze * infants who are likely to move away from the study centre before 3 years of age * children with a recent respiratory tract illness (should have recovered \> 2 weeks) * children with other major respiratory illnesses such as and including Cystic Fibrosis, Chronic Neonatal Lung Disease, pulmonary aspiration syndromes. * children with evidence of a systemic inflammatory or infective condition * children with a history of previous pituitary or ethmoid surgery
Where this trial is running
London
- Royal Brompton and Harefield NHS Foundation Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Andrew Bush, MD — Imperial College London
- Study coordinator: Mindy L Gore, PhD
- Email: m.gore@imperial.ac.uk
- Phone: +442075946857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.