Healthy Lungs: Trial of an intervention programme in children less than two years of age admitted to hospital with severe lower respiratory tract infectio
Not Applicable
Completed
- Conditions
- ower respiratory infection (LRI)Lower respiratory infection (LRI)Respiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12610001095055
- Lead Sponsor
- Health Research Council of New Zealand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Children <2 years age admitted to Counties Manukau District Health Board (CMDHB) with severe LRI (pneumonia and/or bronchiolitis - admission =5 days and/or supplemental oxygen for > 48 hours and/or admission to Intensive care unit, and/or consolidation on CXR) between 1st Aug 2010 & 31st Oct 2011.
Exclusion Criteria
1. Children with more than two prior admissions to hospital with severe LRI as defined by study eligibility criteria.
2. Prematurity <32 weeks gestation.
3. Children with a diagnosis of chronic lung disease.
4. Children known to have chronic health problems of clinical significance affecting daily life: cardiovascular, neurological, immunodeficiency, multiple congenital abnormalities, enteral feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evidence of respiratory morbidity at 24 month follow up during a time of stability, as assessed by: <br>- Abnormal CXR Brasfield score of 22/25 (25/25 = normal). <br>- And/or abnormal clinical examination (defined as clubbing and/or MCIC and/or crackles on auscultation).[24 month]
- Secondary Outcome Measures
Name Time Method Information will be obtained from hospital and GP records which illustrates readmissions with LRI, medically attended LRI/wheezing episodes/asthma diagnosis.[24 months];All Chest X-ray changes[24 months];Bronchiectasis on CT scan[24 months];Nasal swab / sputum cultures[24 months];Estimation by a health economist of the direct health costs of intervention to the public health system.[24 months];Chronic Moist Cough (CMC) on history (defined as daily moist cough for >3 months or 3 or more episodes of moist cough for > 1 month).[24 months]