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Trial registered on ANZCTR


Registration number
ACTRN12619000468123
Ethics application status
Approved
Date submitted
13/03/2019
Date registered
21/03/2019
Date last updated
6/03/2020
Date data sharing statement initially provided
21/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Respiratory Health of Pacific Youth: Risk and Resilience Throughout Childhood
Scientific title
Respiratory Health of Pacific Youth: Risk and Resilience Throughout Childhood
Secondary ID [1] 297700 0
Health Research Council Grant: 17/155
Universal Trial Number (UTN)
Trial acronym
PIF Study
Linked study record
Covariate information for this study including risk and protective factors, confounders and early-life respiratory conditions, will be collected from the below studies' databases:

- Pacific Islands Families Study: The First Two Years of Life (PIF: FTY)
Grant reference number: AIT801
Auckland Regional Ethics Committee X (Reference 99/055 )

- Pacific Islands Families Study: Transition to School (PIF:TTS)
Grant reference number: AITX0202
Northern X Ethics

Health condition
Health condition(s) or problem(s) studied:
Respiratory health 312000 0
Condition category
Condition code
Respiratory 310565 310565 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The respiratory assessment is taking place in one 3-hour visit undertaken by a research nurse.
It includes the below study procedures:
• A clinical assessment including respiratory and general medical histories, current respiratory symptoms and severity, recent respiratory events, and a clinical examination (height, weight, heart rate, breathing rate, blood pressure, listening to particpant's chest breathing and heart sounds, ear nose and throat examination)
• Assessment of lung function with spirometry
• Completing Quality of Life (St. George’s Respiratory Questionnaire and EuroQol five dimensions questionnaire) and sleep questionnaires (Epworth Sleepiness Scale Questionnaire)
• Having blood tests and chest x-ray
Intervention code [1] 313931 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319419 0
Forced Expiratory Volume in 1 second (FEV1) z-score standardised for height, gender and age (ATS/ERS criteria using Global Lung Initiative reference values) as a continuous variable. The FEV1 z-score will be dichotomised to an indicator of z-score < -1.64 for the purpose of estimating population attributable risk.
Timepoint [1] 319419 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [1] 368088 0
(1) Other lung function parameters: Forced Vital Capacity (FVC) measured by spirometry
Timepoint [1] 368088 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [2] 368401 0
(2) Other lung function parameters: FEV1/ FVC ratio measured by spirometry
Timepoint [2] 368401 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [3] 368402 0
(3) Other lung function parameters: Forced Expiratory Flow (FEF) measured by spirometry
Timepoint [3] 368402 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [4] 368403 0
(4) Presence or absence of respiratory disease at the current assessment; doctor-diagnosed disease, presence of symptoms, signs of respiratory disease (wheeze, crackles, chest deformity, clubbing, abnormal lung function) by clinical assessment.
Timepoint [4] 368403 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [5] 368404 0
(5) History of a pulmonary exacerbation in the previous 12 months by clinical assessment.
Timepoint [5] 368404 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [6] 368405 0
(6) Health-related quality of life by St. George’s Respiratory Questionnaire
Timepoint [6] 368405 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [7] 368406 0
(7) Health-related quality of life by EuroQol five dimensions questionnaire
Timepoint [7] 368406 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [8] 368493 0
(8) Health-related quality of life by sleep questionnaire (Epworth Sleepiness Scale Questionnaire)
Timepoint [8] 368493 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [9] 368494 0
(9) Chest x-ray score measured by Brasfield score
Timepoint [9] 368494 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [10] 368495 0
(10) Markers of atopy and asthma- total IgE by blood tests
Timepoint [10] 368495 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [11] 368496 0
(11) Markers of disease -immunoglobulin levels IgG, IgA, IgM by blood tests (composite outcome)
Timepoint [11] 368496 0
At the time of assessing the 18-19 year participants (2018-2019)

Eligibility
Key inclusion criteria
This study draws its participants from an existing cohort; Pacific Islands Families Study.
Minimum age
18 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Those who have permanently dropped out of the study.
2-Those who are living out of Auckland, New Zealand.
3-Those who are unwell on the day of their respiratory assessment.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/06/2018
Date of last participant enrolment
Anticipated
Actual
14/11/2019
Date of last data collection
Anticipated
Actual
14/11/2019
Sample size
Target
500
Accrual to date
Final
466
Recruitment outside Australia
Country [1] 21343 0
New Zealand
State/province [1] 21343 0
Auckland

Funding & Sponsors
Funding source category [1] 302223 0
Government body
Name [1] 302223 0
Health Research Council of New Zealand
Country [1] 302223 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country
New Zealand
Secondary sponsor category [1] 302141 0
None
Name [1] 302141 0
Address [1] 302141 0
Country [1] 302141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302903 0
Central Health and Disability Ethics Committees
Ethics committee address [1] 302903 0
Ethics committee country [1] 302903 0
New Zealand
Date submitted for ethics approval [1] 302903 0
Approval date [1] 302903 0
24/05/2018
Ethics approval number [1] 302903 0
18/CEN/24

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

Contacts
Principal investigator
Name 91790 0
Dr El-Shadan (Dan) Tautolo
Address 91790 0
AUT UNIVERSITY - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country 91790 0
New Zealand
Phone 91790 0
+64 9 921 9999 ext 7527
Fax 91790 0
Email 91790 0
dan.tautolo@aut.ac.nz
Contact person for public queries
Name 91791 0
El-Shadan (Dan) Tautolo
Address 91791 0
AUT UNIVERSITY - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country 91791 0
New Zealand
Phone 91791 0
+64 9 921 9999 ext 7527
Fax 91791 0
Email 91791 0
dan.tautolo@aut.ac.nz
Contact person for scientific queries
Name 91792 0
El-Shadan (Dan) Tautolo
Address 91792 0
AUT UNIVERSITY - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country 91792 0
New Zealand
Phone 91792 0
+64 9 921 9999 ext 7527
Fax 91792 0
Email 91792 0
dan.tautolo@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent to participate in the study includes consent for access to data by immediate study staff, unless required by legislative or regulatory agencies.


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.