Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001062718
Ethics application status
Approved
Date submitted
3/01/2013
Date registered
24/09/2013
Date last updated
3/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Preterm Infant Functional and Clinical Outcomes (PIFCO): Understanding Complex Factors That Influence Long Term Outcomes After Preterm Birth
Scientific title
Observational Study of Physiological and Etiological Markers of Long Term Cardiorespiratory and Developmental Outcomes After Preterm Birth Prior to 32 Weeks Gestation
Secondary ID [1] 281728 0
Nil
Universal Trial Number (UTN)
Trial acronym
PIFCO Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Very Preterm Birth 288029 0
Bronchopulmonary Dysplasia 288030 0
Diaphragm Dysfunction 288031 0
Pulmonary Hypertension 288032 0
Condition category
Condition code
Respiratory 288403 288403 0 0
Other respiratory disorders / diseases
Cardiovascular 288404 288404 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 288405 288405 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Observational study of very preterm infants with intermittent physiological evaluation of:
- immunological function (birth, 1 d, 7 d, 36 w PMA, 1 yr corrected age)
- cardiorespiratory and diaphragm function (primary measurement at 36 w PMA and 1 yr corrected age, with other intermittent measurements as able to be collected)
- neurodevelopmental outcome (1 yr)

Observations will be correlated with data pertaining to antenatal and postnatal exposures including demographic variables, gestation, ventilation, oxygen, steroids, infection, and nutrition
Intervention code [1] 286266 0
Not applicable
Comparator / control treatment
Term born healthy infants will be included as comparators for the 1 year outcomes.
Control group
Active

Outcomes
Primary outcome [1] 288576 0
Thoracic Dysfunction Index derived as a composite function of Lung, Heart and Diaphragm Dysfunction determined using the following techniques at 1 year corrected postnatal age:
a) Multiple Breath Washout (Functional Residual Capacity, Lung Clearance Index)
b) Tidal breathing Flow Volume Loop Analysis (RR, Vt/kg, Vd/kg)
c) Ventilation Perfusion Imbalance (derived from Shunt and Shift assessed on SpO2/FiO2 curves)
d) Pulmonary hypertension determined from R ventricular contractility, pulmonary artery pressures and pulmonary blood flow on echocardiography)
e)transdiaphragmatic pressure generated after magnetic stimulation of the phrenic nerve
Timepoint [1] 288576 0
1 year Corrected Postnatal Age
Primary outcome [2] 288577 0
Thoracic Dysfunction Index derived as a composite function of Lung, Heart and Diaphragm Dysfunction determined using the following techniques at 36 w postmenstrual age:
a) Multiple Breath Washout (Functional Residual Capacity, Lung Clearance Index)
b) Tidal breathing Flow Volume Loop Analysis (RR, Vt/kg, Vd/kg)
c) Ventilation Perfusion Imbalance (derived from Shunt and Shift assessed on SpO2/FiO2 curves)
d) Pulmonary hypertension determined from R ventricular contractility, pulmonary artery pressures and pulmonary blood flow on echocardiography)
e)transdiaphragmatic pressure generated after magnetic stimulation of the phrenic nerve
Timepoint [2] 288577 0
36 w postmenstrual age (PMA)
Secondary outcome [1] 300492 0
Neurodevelopmental Outcome (Griffith's Test)
Timepoint [1] 300492 0
1 year corrected postnatal age

Eligibility
Key inclusion criteria
Inpatient at King Edward Memorial Hospital
Born at < 32 w gestation (postmenstrual age)

Term comparison group - healthy uncomplicated deliveries between 37 and 42 w postmenstrual age
Minimum age
0 Hours
Maximum age
14 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Informed consent unable to be obtained
Major congenital abnormalities likely to impact cardiorespiratory function

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We will use multivariable logistic regression to predict the development and severity of BPD taking into account primary antecedent adverse perinatal exposures and function of the lungs, heart, pulmonary circulation and the diaphragm. Based on an incidence of NICHD defined BPD of 25% in very preterm infants at KEMH, a cohort of 400 infants evaluated at 1 year of age used in the logistic regression analysis will attain >80% power to detect odds ratios (OR) of 1.6-1.8 associated with change in the independent continuous predictors from their mean by one standard deviation (i.e. risk increase 6-10%), and ORs of 2.0-3.0 associated with categorical predictors (i.e. risk increase 12-16%) while controlling of other simultaneous covariates with partial R2=0.15 (PASS 2008 Power and Sample Size Program For Windows, Kaysville, Utah). Linear regression analysis will be used to investigate factors associated with lung, heart and pulmonary circulation, chest wall and diaphragm. All linear multiple regression analyses will attain =90% power to detect R2=0.05 attributable to a given risk factor while simultaneously controlling for up to 12 additional covariates in the model.
A cohort size of 400 infants at 1 year of age requires recruitment of 500 neonates, as our past experience indicates 20% attrition at 1 year of age (illness, failure to sleep, technical difficulties and withdrawn consent). Assuming 25% of these will have BPD (mild, moderate or severe) and ~ 12% will have moderate to severe BPD, we will target recruitment for neonatal studies of a total of 125 <32 w GA infants with BPD, including 60 infants with moderate-severe BPD out of the total cohort of 500 infants. Approximately 300 very preterm (< 32 w GA) are born at KEMH each year. The factor determining the required recruitment duration is the incidence of BPD: With 25% of < 32 w GA infants developing BPD, we expect approximately 75 eligible preterm infants with BPD (any severity) each year. Our recent experience is that we are able to obtain consent for lung and diaphragm function studies prior to discharge in at least 50-60 % of this pool (40-45 BPD infants/year) and echocardiographic studies in close to 100 % of infants. We obtain acceptable and repeatable lung function data in at least 80% of infants tested providing us with comprehensive functional information within the neonatal period on ~35 infants with BPD each year, requiring ~3.6 years for recruitment of the full cohort.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2013
Actual
24/09/2013
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1530 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 6153 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 286517 0
Government body
Name [1] 286517 0
National Health and Medical Research Council (NHMRC)
Country [1] 286517 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway,
Crawley, 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 285304 0
Hospital
Name [1] 285304 0
King Edward Memorial Hospital
Address [1] 285304 0
374 Bagot Rd, Subiaco, 6008
Western Australia
Country [1] 285304 0
Australia
Secondary sponsor category [2] 285305 0
Hospital
Name [2] 285305 0
Princess Margaret Hospital for Children
Address [2] 285305 0
Roberts Rd,
Subiaco, 6008
Western Australia
Country [2] 285305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288590 0
Women and Newborn Health Service Human Ethics Committee
Ethics committee address [1] 288590 0
Ethics committee country [1] 288590 0
Australia
Date submitted for ethics approval [1] 288590 0
20/08/2013
Approval date [1] 288590 0
03/09/2013
Ethics approval number [1] 288590 0
2013-091 EW

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

Contacts
Principal investigator
Name 36830 0
Prof Jane Pillow
Address 36830 0
c/- School of Human Sciences and UWA Centre for Neonatal Research and Education,
M309, The University of Western Australia,
35 Stirling Highway,
Crawley, 6009
Western Australia
Country 36830 0
Australia
Phone 36830 0
+61 8 6488 3318
Fax 36830 0
+61 8 6488 1051
Email 36830 0
[email protected]
Contact person for public queries
Name 36831 0
Diane Arnott
Address 36831 0
c/- UWA Centre for Neonatal Research and Education
1st Floor, King Edward Memorial Hospital,
374 Bagot Rd,
Subiaco, 6008
Western Australia
Country 36831 0
Australia
Phone 36831 0
61 8 9340 1260
Fax 36831 0
61 8 9340 1266
Email 36831 0
[email protected]
Contact person for scientific queries
Name 36832 0
Jane Pillow
Address 36832 0
c/- School of Human Sciences and UWA Centre for Neonatal Research and Education,
M309, The University of Western Australia,
35 Stirling Highway,
Crawley, 6009
Western Australia
Country 36832 0
Australia
Phone 36832 0
+61 8 6488 3318
Fax 36832 0
+61 8 6488 1051
Email 36832 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
SourceTitleYear of PublicationDOI
EmbaseSimplified bedside assessment of pulmonary gas exchange in very preterm infants at 36 weeks' postmenstrual age.2021https://dx.doi.org/10.1136/thoraxjnl-2020-214659
EmbaseThe ventilatory response to hypoxia is blunted in some preterm infants during the second year of life.2022https://dx.doi.org/10.3389/fped.2022.974643
N.B. These documents automatically identified may not have been verified by the study sponsor.