Healthy Lungs Study: A Randomised Controlled Trial of a Community Intervention Programme Versus Usual Care to Prevent Chronic Respiratory Symptoms in Children Following Severe Bronchiolitis or Pneumonia

Background: Bronchiectasis prevalence has increased, especially in indigenous children. One evolutionary pathway follows hospitalisation with severe lower respiratory tract infection (LRTI) in early childhood. We aimed to reduce the intermediate respiratory morbidity with an intervention programme introduced at discharge. Methods: This randomised, controlled, single-blind trial enrolled children aged <2 years hospitalised for severe LRTI to intervention or control. Intervention was minimum three monthly community assessments treating wet cough with prolonged antibiotics and referral for investigation of non-responders. All other health issues were addressed, health resilience behaviours encouraged, with referrals for environmental concerns (housing, smoking). Controls followed the usual pathway of caregiver-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 when in stable health. This study is registered ACTRN12610001095055. Findings: March 2011-September 2012, we enrolled 400 children (203 intervention, 197 control); 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, p=0•63), abnormal examination (21•7% intervention, 23•9% controls, p=0•75) or Brasfield score ≤22 (32•4% intervention, 37•9% control, p=0•3). Twelve (all intervention) developed bronchiectasis. Interpretation: We have identified children at high risk of developing chronic suppurative lung disease. This intervention programme did not improve outcomes but future preventative strategies should target this population. Trial Registration Number: This study is registered at Australian and New Zealand Clinical Trials RegistryACTRN12610001095055. Funding: Health Research Council of New Zealand (10/510), Asthma and Respiratory Foundation, Lottery Health Research, and Maurice and Phyllis Paykel Trust. Declaration of Interest: We declare that we have no conflicts of interests. Ethical Approval: The study was approved by the Human Disability Ethics Committee NTX/10/09/094. Caregivers provided written, informed consent prior to enrolment.