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Trial registered on ANZCTR


Registration number
ACTRN12610001095055
Ethics application status
Approved
Date submitted
2/12/2010
Date registered
14/12/2010
Date last updated
6/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Lungs: Trial of an intervention programme in children less than two years of age admitted to hospital with severe lower respiratory tract infection
Scientific title
Randomised control trial of an intervention programme based on the cystic fibrosis model of care versus standard medical care in children less than two years of age admitted to hospital with severe lower respiratory tract infection to prevent chronic lung disease
Secondary ID [1] 253224 0
NTX/10/09/094
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower respiratory infection (LRI) 258760 0
Condition category
Condition code
Respiratory 258906 258906 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257695 0
Other interventions
Comparator / control treatment
The control families will receive the current ‘usual care’ which is GP review for family directed health concerns with re-referral to paediatric services as necessary. They will then be followed up for specialist review at 24 months.
Control group
Active

Outcomes
Primary outcome [1] 259762 0
Evidence of respiratory morbidity at 24 month follow up during a time of stability, as assessed by:
- Abnormal CXR Brasfield score of 22/25 (25/25 = normal).
- And/or abnormal clinical examination (defined as clubbing and/or MCIC and/or crackles on auscultation).
Timepoint [1] 259762 0
24 month
Secondary outcome [1] 268524 0
Information will be obtained from hospital and GP records which illustrates readmissions with LRI, medically attended LRI/wheezing episodes/asthma diagnosis.
Timepoint [1] 268524 0
24 months
Secondary outcome [2] 268525 0
All Chest X-ray changes
Timepoint [2] 268525 0
24 months
Secondary outcome [3] 268526 0
Bronchiectasis on CT scan
Timepoint [3] 268526 0
24 months
Secondary outcome [4] 268527 0
Nasal swab / sputum cultures
Timepoint [4] 268527 0
24 months
Secondary outcome [5] 268528 0
Estimation by a health economist of the direct health costs of intervention to the public health system.
Timepoint [5] 268528 0
24 months
Secondary outcome [6] 268529 0
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).
Timepoint [6] 268529 0
24 months

Eligibility
Key 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.
Minimum age
No limit
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once inclusion / exclusion criteria are checked from medical records potential participant’s parents or legal guardians will be contacted by investigator or research nurse and be invited to participate. Once consented participants will be randomised via sealed envelope to one of two groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of patient number to intervention or control will be achieved using block randomisation, with random block size, to ensure the participants are balanced in the 2 groups. A set of 400 sealed, numbered envelopes containing the study arm for that number will be provided by CCREP to the study coordinator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and analysis: The intention was to enrol 400 children assuming 80% retention at 24 months. Based on the pilot study, assuming 40% of controls would have chronic respiratory outcomes present, there was 98% power to detect a 50% reduction at the 5% level of significance and 80% power to detect a 38% reduction. The analysis was on intention-to-treat with sensitivity analysis carried out on all those randomised to examine the possible effect of loss to follow-up. The outcome measures were all binary or ordinal so the intervention effect was assessed by using binary or ordinal logistic regression including confounding variables of age of enrolment, season of enrolment and enrolment diagnosis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
3/03/2011
Date of last participant enrolment
Anticipated
Actual
30/09/2012
Date of last data collection
Anticipated
Actual
3/12/2014
Sample size
Target
400
Accrual to date
Final
400
Recruitment outside Australia
Country [1] 3071 0
New Zealand
State/province [1] 3071 0

Funding & Sponsors
Funding source category [1] 258168 0
Government body
Name [1] 258168 0
Health Research Council of New Zealand
Country [1] 258168 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541
Wellesley Street
Auckland, 1141
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257342 0
Charities/Societies/Foundations
Name [1] 257342 0
Middlemore Clinical Trials
Address [1] 257342 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country [1] 257342 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260155 0
Northern X Regional Ethics Committee
Ethics committee address [1] 260155 0
Ethics committee country [1] 260155 0
New Zealand
Date submitted for ethics approval [1] 260155 0
25/08/2010
Approval date [1] 260155 0
30/09/2010
Ethics approval number [1] 260155 0
NTX/10/09/094

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31981 0
Dr Adrian Trenholme
Address 31981 0
Kidz First
Middlemore Hospital
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 31981 0
New Zealand
Phone 31981 0
+ 64 9 2760000
Fax 31981 0
+ 64 9 250 3878
Email 31981 0
a.trenholme@middlemore.co.nz
Contact person for public queries
Name 15228 0
Catherine Howie
Address 15228 0
Middlemore Clinical Trials
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 15228 0
New Zealand
Phone 15228 0
+64 9 276 0044 extn 9153
Fax 15228 0
+ 649 250 3878
Email 15228 0
Catherine.howie@mmclintrials.nz
Contact person for scientific queries
Name 6156 0
Cass Byrnes
Address 6156 0
Kidz First Administration
Private Bag 93311
Otahuhu
Auckland 1640
Country 6156 0
New Zealand
Phone 6156 0
+64 9 276 0000
Fax 6156 0
Email 6156 0
atrenholme@middlemore.co.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProspective community programme versus parent-driven care to prevent respiratory morbidity in children following hospitalisation with severe bronchiolitis or pneumonia.2020https://dx.doi.org/10.1136/thoraxjnl-2019-213142
N.B. These documents automatically identified may not have been verified by the study sponsor.