None listed
Conditions
Brief summary
We are seeking a workable solution to the inequitable and escalating numbers of Maaori and Pacific children with chronic lung disease which the current healthcare system is struggling to accommodate. The primary aim is to determine whether an international model of care from the specialised patient population of CF delivered in tertiary hospitals can be adapted as an intervention programme and be delivered in a local and community setting to NZ Maaori and Pacific paediatric populations at high risk of developing chronic lung disease. Parents of children admitted to hospital with a severe lower respiratory tract infection will be approached for consent, and be randomised to an ‘intervention programme group’ or a ‘control group’ of usual care. Both groups will be followed throughout the two years of the study and will receive a medical examination to assess their respiratory health at 24 months.
Interventions
The intervention programme is based on the Cystic Fibrosis model of care for early childhood with regular clinic review for any deviation from normal health and to institute early treatment and/or preventative care. Reviews will be undertaken as a minimum at 1-3, 6, 9, 12, 15, 18, 21 and 24 months after the day 0 assessment and as required in one of three community centres (Otara, Mangere, Manurewa) staffed by the nominated general practitioner (GP) or nurse practitioner and practice nurse.
Sponsors
Health Research Council of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 2 Years
Healthy volunteers
No
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.
Outcome results
None listed