Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000215325
Ethics application status
Approved
Date submitted
14/04/2008
Date registered
21/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining peak inspiratory flow during regular breathing in both healthy and lung sick patients
Scientific title
A study to measure the peak flow of infants aged 0-2 years with either healthy lungs or with bronchiolitis to determine peak flow values in both these groups.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 3050 0
Normal lung physiology 3051 0
Condition category
Condition code
Respiratory 3206 3206 0 0
Other respiratory disorders / diseases
Respiratory 3207 3207 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Peak flow will be measured in infants aged 0-2 years suffering from bronchiolitis. Peak flow will be measured using an ultrasonic flow meter for a time period of one minute. The flow sensor will be attached either via a face mask or if the infant is intubated via the endotracheal tube.
Intervention code [1] 2800 0
Not applicable
Comparator / control treatment
The peak flow rates of infants aged 0-2 years with healthy lungs will be measured using an ultrasonic flow sensor for a time period of one minute. The flow sensor will be attached either via a face mask or if the infant is intubated via the endotracheal tube.
Control group
Active

Outcomes
Primary outcome [1] 4092 0
The primary outcome measure for the study is peak flow measurement collected in 30 lung healthy infants aged 0-2 years and 30 infants with bronchiolitis aged 0-2 years. Peak flow will be measured using an ultrasonic flow meter.
Timepoint [1] 4092 0
The peak flow measurement will be recorded for one minute in all infants
Secondary outcome [1] 6890 0
None
Timepoint [1] 6890 0
n/a

Eligibility
Key inclusion criteria
1. Infants aged 0-2 years
2. Infants about to undergo surgery not related to their respiratory system (healthy lung group)
3. Infants diagnosed with bronchiolitis in repsiratory failure (lung sick group)
Minimum age
0 Years
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infants aged > 2 years
2. Infants not breathing spontaneously
3. Infants whose condition limits their ability to participate
4. Infants where informed consent cannot be obtained from a parent or legal guardian

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 914 0
New Zealand
State/province [1] 914 0

Funding & Sponsors
Funding source category [1] 3301 0
Commercial sector/Industry
Name [1] 3301 0
Fisher and Paykel Healthcare
Country [1] 3301 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland
Country
New Zealand
Secondary sponsor category [1] 2955 0
None
Name [1] 2955 0
Address [1] 2955 0
Country [1] 2955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5287 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5287 0
Ministry of Health
3rd Floor
BNZ Building
354 Victoria Street
PO Box 1031
Hamilton
Ethics committee country [1] 5287 0
New Zealand
Date submitted for ethics approval [1] 5287 0
Approval date [1] 5287 0
18/04/2007
Ethics approval number [1] 5287 0

Summary
Brief summary
Respiratory conditions are a common cause for hospital admission in the paediatric population, however little is known about paediatric respiratory function during regular breathing in these patients. The aim of this study is to determine the peak inspiratory flow rates, of both healthy and lung sick infants. It is hoped that this study will increase understanding of paediatric respiratory physiology during respiratory illness.
The study will be a prospective, observational, unblinded study on infants with both normal and impaired respiratory function. The primary outcome will be Peak inspiratory flow – the maximum flow rate (LPM) recorded throughout the inspiration phase, during regular breathing.
Once consent has been granted, the researcher will attach the flow sensor either via a face mask or if the infant is intubated via the endotrachela tube.
Participants will be infants between 0 month and 2 years, recruited from Starship Childrens hospital, after obtained informed consent from parents/caregivers. It is approximated that 30 patients will be required in both groups.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 28529 0
Address 28529 0
Country 28529 0
Phone 28529 0
Fax 28529 0
Email 28529 0
Contact person for public queries
Name 11686 0
Laura-Clare Whelan
Address 11686 0
Paediatric Intensive Care Unit
Level 2
Starship Children's Hospital
Private Bag 92024
Auckland
Country 11686 0
New Zealand
Phone 11686 0
+ 64 9 3074949 ext. 23070
Fax 11686 0
Email 11686 0
[email protected]
Contact person for scientific queries
Name 2614 0
Dr David Buckley
Address 2614 0
Paediatric Intensive Care Unit
Level 2
Starship Children's Hospital
Private Bag 92024
Auckland
Country 2614 0
New Zealand
Phone 2614 0
+ 64 9 3074903
Fax 2614 0
Email 2614 0
[email protected]

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
No additional documents have been identified.