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Development of risk score for diagnosing bronchiectasis in children

Development of a novel diagnostic approach enabling the early detection of bronchiectasis in children

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001242415
Enrollment
450
Registered
2025-11-07
Start date
2025-12-01
Completion date
2029-06-30
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The early recognition of bronchiectasis (BE) in children is important for immediate and future outcomes, whilst late diagnosis is associated with poorer lung function and more severe bronchiectasis. We plan a consumer co-designed cohort study to develop a diagnostic approach whereby health practitioners can confidently use to refer children with chronic wet cough appropriately. We aim to develop a diagnostic algorithm enriched with systemic (blood) gene expression signatures to enhance accuracy. We will then test our algorithm in an independent cohort, using data from further children recruited to this study plus that from our current MRFF-funded study called LEAP-Cough.

Interventions

We plan an international multicentre cohort study that will lead to an algorithm enabling clinicians to appropriately refer children with chronic wet cough (CWC) for a chest computed tomography (cCT) to diagnose bronchiectasis. Based on presence/absence of clinical features, scores will allocated whereby children with scores above a certain cut-off will undertake a chest CT scan. In a subgroup of children who have certain features present, a CT scan will be undertaken irrespective of the scor

We plan an international multicentre cohort study that will lead to an algorithm enabling clinicians to appropriately refer children with chronic wet cough (CWC) for a chest computed tomography (cCT) to diagnose bronchiectasis. Based on presence/absence of clinical features, scores will allocated whereby children with scores above a certain cut-off will undertake a chest CT scan. In a subgroup of children who have certain features present, a CT scan will be undertaken irrespective of the score. In a subgroup of children, we will also determine if a gene expression signature can be identified from their peripheral blood. Chronic wet cough is defined as daily wet or productive cough lasting >4 weeks duration. Data collected are: Sociodemographic (eg. age, sex, race, family and household size, active or passive smoking/vaping, immunisation and family history, medications) from carers and medical notes, routine clinical data (eg. clinical history and spirometry) and when possible blood (for gene expression and for a biobank). and sputum (for microbiology and biobank). will collect surveillance data (e.g. medical visits, treatments, other interventions, time off work/school, etc.) every month using monthly surverys and from the medical notes. Children will be followed up for 12 months. Data will be collected directly from the parents/carers and medical notes Based on current recommendations, children with CWC who have chest radiograhs suggestive of bronchiectasis, have P. aeruginosa or non-tubercolosis isolated in a lower airway specimen or digital clubbing, will get a cCCT. For those without any of these features, a score will be given to the presence of other features. This scoring is a preliminary score that will be modified when the study is completed. based on statiscal analysis. These features include: Presence of tracheomalacia, recurrent PBB, “severe asthma” or aspirations risks, CWC duration, CWC persists after 4 weeks of antibiotics, and history of community pneumonia, hospitalised respiratory infection, human immunodeficiency virus or tuberculosis. Additionally, we will include other possible factors if other such data is considered important based on our observational study. The algorithm will be developed as part of a co-design process between clinicians and parents. The process will be for the duration of the study. This will occur via regular team meetings (at least 2 consumers are present in each meeting), feedback meetings (occurs twice a year, and direct one-to-one discussions with parents/consumers. Stake holders were already consulted in the draft algorithm. WIth results available, they will be resulted and invited to provide feedback.

Sponsors

Menzies School of Health Research
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
3 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

(a) children (aged 3-mo to 18y) and (b) with chronic wet cough (>4-wks duration).

Exclusion criteria

Children (a) with cystic fibrosis or previous bronchiectasis diagnosis, (b) are acutely unwell (fever >38 degrees C, tachypnoea, etc), (c) inborn error of immunity (eg. primary immune deficiency), (d) undergoing treatment for cancer, (e) receiving treatment that impairs systemic immunity, or (f) unable to be followed (for 6-mo).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026