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Search / Trial NCT04063631

Pulmonary Epithelium, Immunology and Development of Asthma: Breathing Together

Launched by IMPERIAL COLLEGE LONDON · Aug 20, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Asthma

ClinConnect Summary

The "Breathing Together" study is looking into why some babies who wheeze develop asthma as they grow up. Researchers want to see if these babies have different airway cells in their noses at birth and how those cells change over time. The study will last for three years, and parents will fill out a monthly health questionnaire about their child's well-being. Babies will undergo some routine tests, including urine and blood samples, as well as swabs taken from their nose and throat, to help understand their health at ages 5-10 days, one year, and three years old.

To participate, families should have a baby aged 0-10 days or be expectant mothers. Eligible children may have had wheezing issues or other allergy-related conditions or may not have wheezed at all but have signs of allergies. It's important that the baby is healthy enough for elective surgery, as some samples will be taken during that procedure. Parents can expect regular follow-ups, and additional swabs will be collected if their child experiences wheezing episodes in the first three years. This study aims to uncover important information about asthma development to help improve future treatments.

Gender

ALL

Eligibility 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

About Imperial College London

Imperial College London is a world-renowned research institution based in the United Kingdom, recognized for its commitment to advancing medical science and improving patient care through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, Imperial combines expertise across various fields, including medicine, engineering, and business, to drive breakthroughs in healthcare. The institution’s robust clinical trial programs are designed to evaluate new therapies and interventions, ensuring rigorous scientific standards and ethical practices while aiming to translate research findings into tangible benefits for patients and society.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Andrew Bush, MD

Principal Investigator

Imperial College London

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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