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Abstract
Background Hospitalisation with severe lower respiratory tract infection (LRTI) in early childhood is associated with ongoing respiratory symptoms and possible later development of bronchiectasis. We aimed to reduce this intermediate respiratory morbidity with a community intervention programme at time of discharge.
Methods This randomised, controlled, single-blind trial enrolled children aged <2 years hospitalised for severe LRTI to ‘intervention’ or ‘control’. Intervention was three monthly community clinics treating wet cough with prolonged antibiotics referring non-responders. All other health issues were addressed, and health resilience behaviours were encouraged, with referrals for housing or smoking concerns. Controls followed the usual pathway of parent-initiated healthcare access. After 24 months, all children were assessed by a paediatrician blinded to randomisation for primary outcomes of wet cough, abnormal examination (crackles or clubbing) or chest X-ray Brasfield score ≤22.
Findings 400 children (203 intervention, 197 control) were enrolled in 2011–2012; mean age 6.9 months, 230 boys, 87% Maori/Pasifika ethnicity and 83% from the most deprived quintile. Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17). Twelve (all intervention) were diagnosed with bronchiectasis within this timeframe.
Interpretation We have identified children at high risk of ongoing respiratory disease following hospital admission with severe LRTI in whom this intervention programme did not change outcomes over 2 years.
Trial registration number ACTRN12610001095055.
- paediatric lung disaese
- pneumonia
- respiratory infection
- bronchiectasis
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Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
CAB and AT are joint first authors.
Contributors CAB and AT are joint principal investigators and first authors who developed the study concept and study design, established the protocol, obtained ethics and funding, oversaw the study, reviewed the respiratory and paediatric referrals, respectively, and fielded queries from the community clinics. They undertook data analysis and interpretation with full access to the data, drafted the initial manuscript and edited and approved the final version. CM developed the study design and protocols and assisted with funding applications and initial enrolments. LLC coordinated the study and assisted with funding applications, ethics and governance. SL coordinated enrolments, clinics, data collection and cleaning and and assisted with data analysis. HA and JAH developed study design and protocols, and with KH, AE and CM each ran one clinic site in the community for intervention. RM scored all radiology blinded to study group. CM and FCM contributed to design of final assessments and undertook these blinded to group randomisation. MJ assessed all respiratory referrals and ensured children connected with appropriate services at study end. JS was the lead study statistician and assisted with prospectively setting study outcomes and analysis, and with CC did data cleaning, analysis and interpretation, with interpretation at study end. AV contributed to data analysis, interpretation and drafting of manuscript. WL was lead epidemiologist and contributed to data analysis and drafting of manuscript. HM and TP provided cultural guidance into study design, set-up and running with regard to Māori and Pasifika communities, respectively. All investigators contributed to final data interpretation and manuscript drafts, and all approved the final manuscript for submission.
Funding Health Research Council of New Zealand (10/510), Asthma and Respiratory Foundation, Lottery Health Research, and Maurice and Phyllis Paykel Trust.
Competing interests CAB and AT received grants to undertake the research from the fund holders that are listed including the Health Research Council of New Zealand, Asthma and Respiratory Foundation of New Zealand, Lottery Health Research, New Zealand and Maurice and Phyllis Paykel Trust, New Zealand.
Patient consent for publication Not required.
Ethics approval The study was approved by the National Ethics Committee (NTX/10/09/094) and the Māori Research Review Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. The overall data results are available as part of the manuscript and supplementary tables, but if individual data points wanted, this could be provided in response to a reasonable request.