Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000628943
Ethics application status
Approved
Date submitted
20/06/2011
Date registered
21/06/2011
Date last updated
2/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Is bias gas flow in ventilated preterm babies related to lung injury and risk of bronchopulmonary dysplasia?
Scientific title
Ventilator bias gas flows in extremely preterm or extremely low birth weight babies: does a low bias gas flow compared with standard settings decrease concentrations of IL-8 in tracheal secretions and blood and the number of ventilated days?
Secondary ID [1] 262412 0
Nil
Universal Trial Number (UTN)
U1111-1122-3024
Trial acronym
FLoRa: Flows at Lower Rates
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ventilator-induced lung injury 268107 0
Bronchopulmonary dysplasia 268108 0
Extreme preterm birth 268110 0
Extremely low birth weight 268111 0
Condition category
Condition code
Respiratory 268250 268250 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 268254 268254 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:Conventional ventilation via ETT at a bias gas flow of 4 L/min
Arm 2: Conventional ventilation via ETT at a bias gas flow of 10 L/min
Duration; each time ventilation is indicated up to 36 weeks’ corrected gestational age
Intervention code [1] 266792 0
Treatment: Devices
Comparator / control treatment
Standard treatment of ventilation at a bias gas flow of 10 L/min
Control group
Active

Outcomes
Primary outcome [1] 268977 0
Level of IL-8 in tracheal aspirate
Timepoint [1] 268977 0
Assessed at 24 hours after onset of ventilation
Primary outcome [2] 268978 0
Number of ventilated days
Timepoint [2] 268978 0
discharge from neonatal intensive care unit or death
Secondary outcome [1] 276739 0
Levels of inflammatory markers IL-8, IL1-beta, IL-6 and TNF-alpha and levels of the oxidative stress markers myeloperoxidase activity, glutathione sulfonamide and chlorotyrosine in blood and tracheal aspirate
Timepoint [1] 276739 0
Assessed at 24, 72 and 120 hours after onset of ventilation
Secondary outcome [2] 276740 0
Bronchopulmonary dysplasia
Timepoint [2] 276740 0
36 weeks corrected postmenstrual age
Secondary outcome [3] 276741 0
mRNA Levels of early response genes CYR61, CTGF and EGR1 in blood samples, measured by molecular analysis
Timepoint [3] 276741 0
Assessed at 24, 72 and 120 hours after onset of ventilation
Secondary outcome [4] 276742 0
Composite outcome of death or neonatal morbidity, including pulmonary interstitial emphysema, pulmonary haemorrhage, intraventricular haemorrhage (grade III and IV), periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis or persistent ductus arteriosus.
Timepoint [4] 276742 0
36 weeks corrected postmenstrual age or death
Secondary outcome [5] 276743 0
Occurrence of asthma or wheezing assessed by history and prescription of bronchodilators or inhaled corticosteroids
Timepoint [5] 276743 0
2 years

Eligibility
Key inclusion criteria
Preterm baby born before 28 weeks of gestation or birth weight < 1,000 g and the need for mechanical ventilation in the first week of life
Minimum age
0 Days
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital cardio-respiratory anomalies and known chromosomal or genetic abnormalities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation from random number table stratified by centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
27/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 3631 0
New Zealand
State/province [1] 3631 0
Auckland
Country [2] 3632 0
New Zealand
State/province [2] 3632 0
Christchurch

Funding & Sponsors
Funding source category [1] 267261 0
Charities/Societies/Foundations
Name [1] 267261 0
Anonymous philanthropic donation
Country [1] 267261 0
New Zealand
Funding source category [2] 289023 0
Charities/Societies/Foundations
Name [2] 289023 0
Cure Kids
Country [2] 289023 0
New Zealand
Funding source category [3] 289024 0
Charities/Societies/Foundations
Name [3] 289024 0
A+ Charitable trust fund
Country [3] 289024 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Liggins Institute
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 266324 0
Hospital
Name [1] 266324 0
Auckland City Hospital
Address [1] 266324 0
Newborn Services
National Women's Health
Auckland City Hospital
Support Building, level 9
PO Box 92024
Auckland 1023
Country [1] 266324 0
New Zealand
Other collaborator category [1] 252066 0
University
Name [1] 252066 0
University of Otago
Address [1] 252066 0
Department of Paediatrics
Christchurch Clinical School, University of Otago
P.O. Box 4345, Level 5, 2 Riccarton Avenue, Christchurch 8140
Country [1] 252066 0
New Zealand
Other collaborator category [2] 252067 0
Hospital
Name [2] 252067 0
Royal Women's Hospital
Address [2] 252067 0
Royal Women's Hospital
Flemington Road
Parkville
Melbourne
Victoria 3050
Country [2] 252067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269256 0
Multi-region ethics committee
Ethics committee address [1] 269256 0
Ethics committee country [1] 269256 0
New Zealand
Date submitted for ethics approval [1] 269256 0
01/07/2011
Approval date [1] 269256 0
29/08/2011
Ethics approval number [1] 269256 0
MEC11/08/068

Summary
Brief summary
Mechanical ventilation of preterm babies has increased their survival over the last decades; however, ventilation also results in injury to the delicate immature lung. Several aspects of ventilation have been identified as contributing to this injury, including the pressure generated by the ventilator and the volume of gas delivered, which have led to advances in ventilatory strategies. To generate the pressure and tidal volume necessary to ventilate a patient, a ventilator applies a continuous bias gas flow running through the ventilator circuit. During ventilation of the preterm baby, this bias gas flow is normally set at 8-10 L/min, independent of babies’ weights and without evidence for this to be the correct setting. However, high compared to low ventilator bias gas flows have been proven to be more injurious for the immature lamb lung. This study will compare preterm babies ventilated at either the standard gas flow of 10 L/min, or a low gas flow of 4 L/min. Outcomes will be measurement of levels of inflammatory markers and duration and intensity of respiratory support
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32756 0
Dr Katinka Bach
Address 32756 0
Newborn Services
Auckland City Hospital
Support Building level 9
Private bag 92024
Auckland 1023
Country 32756 0
New Zealand
Phone 32756 0
+64 9 307 4949, ext 23526
Fax 32756 0
Email 32756 0
[email protected]
Contact person for public queries
Name 16003 0
Dr Dr Katinka Bach
Address 16003 0
Newborn Services, Auckland City Hospital
Support Building, level 9
PO Box 92024
Auckland 1023
Country 16003 0
New Zealand
Phone 16003 0
+64 21 064 3439
Fax 16003 0
+64 9 3754373
Email 16003 0
[email protected]
Contact person for scientific queries
Name 6931 0
Prof Frank Bloomfield
Address 6931 0
Liggins Institute
University of Auckland
Private Bag 92019
Auckland 1142
Country 6931 0
New Zealand
Phone 6931 0
+64 9 9236107
Fax 6931 0
+64 9 3737497
Email 6931 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23192Study protocol  [email protected]
23193Statistical analysis plan  [email protected]
23194Informed consent form  [email protected]
23195Ethical approval  [email protected]

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.