Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000202763
Ethics application status
Approved
Date submitted
19/02/2013
Date registered
19/02/2013
Date last updated
14/01/2021
Date data sharing statement initially provided
4/09/2019
Date results information initially provided
4/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Breathing for Life Trial: A randomised controlled trial of fractional exhaled nitric oxide based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health
Scientific title
The Breathing for Life Trial: A multi-centre randomised controlled trial of fractional exhaled nitric oxide based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health.
Secondary ID [1] 281396 0
Nil
Universal Trial Number (UTN)
Trial acronym
BLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma during pregnancy 287633 0
Condition category
Condition code
Respiratory 287965 287965 0 0
Asthma
Reproductive Health and Childbirth 287966 287966 0 0
Antenatal care
Reproductive Health and Childbirth 287967 287967 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FENO Algorithm: Fractional exhaled nitric oxide (FENO) is a non-invasive marker of airway inflammation in asthma. FENO will be measured at monthly visits during the second and third trimesters pregnancy and the level used to adjust maintenance asthma therapy. When FENO is high, inhaled corticosteroid therapy will be increased, when FENO is in a mid-range no change will be made to ICS, and when FENO is low, ICS will be decreased. If symptoms are present (assessed using the asthma control questionnaire), long acting beta agonist (LABA) will be added.
Intervention code [1] 285875 0
Other interventions
Comparator / control treatment
Standardised Usual Care: Pregnant women will receive an initial asthma assessment, and asthma therapy (inhaled corticosteroid and long acting beta agonist) will be adjusted by their usual care providers. FENO measurements will not be made.
Control group
Active

Outcomes
Primary outcome [1] 288177 0
Adverse perinatal outcome (either preterm birth [delivery <37 completed weeks gestation], intrauterine growth restriction [birth weight <10th centile], perinatal mortality [stillbirth or neonatal death within first 28 days of life] or neonatal hospitalisation at birth
Timepoint [1] 288177 0
First 28 days of life
Secondary outcome [1] 299546 0
Preterm birth (delivery at <37 completed weeks gestation)
Timepoint [1] 299546 0
Birth
Secondary outcome [2] 299547 0
Intrauterine growth restriction (Birth weight <10th centile)
Timepoint [2] 299547 0
Birth
Secondary outcome [3] 299548 0
Perinatal mortality
Timepoint [3] 299548 0
First 28 days of life
Secondary outcome [4] 299549 0
Neonatal hospitalisation at birth
Timepoint [4] 299549 0
Birth
Secondary outcome [5] 299550 0
Maternal asthma exacerbations requiring medical intervention during pregnancy
Timepoint [5] 299550 0
End of pregnancy
Secondary outcome [6] 299551 0
Maternal hospitalisations for asthma during pregnancy
Timepoint [6] 299551 0
End of pregnancy
Secondary outcome [7] 299552 0
Multiple episodes of bronchiolitis in the first year of life, parent-report by the Questionnaire on respiratory symptoms in preschool children (Strippoli et al. Arch Dis Child. 2007), which has demonstrated test-retest reliability.
Timepoint [7] 299552 0
12 months of age
Secondary outcome [8] 299553 0
Multiple episodes of croup in the first year of life, parent-report by the Questionnaire on respiratory symptoms in preschool children (Strippoli et al. Arch Dis Child. 2007), which has demonstrated test-retest reliability.
Timepoint [8] 299553 0
12 months of age
Secondary outcome [9] 300643 0
Atopy at age 3
Timepoint [9] 300643 0
3 years of age
Secondary outcome [10] 300644 0
Physician diagnosed asthma at age 6
Timepoint [10] 300644 0
6 years of age
Secondary outcome [11] 301011 0
Mean birth weight
Timepoint [11] 301011 0
Birth
Secondary outcome [12] 301012 0
Hospitalisation for bronchiolitis in first year of life
Timepoint [12] 301012 0
12 months of age
Secondary outcome [13] 301300 0
Maternal hospitalisations or emergency department presentations for asthma during pregnancy
Timepoint [13] 301300 0
End of pregnancy
Secondary outcome [14] 301301 0
Hospitalisation or emergency department presentation for severe respiratory illness (bronchiolitis, croup or wheezing) in the first year of life
Timepoint [14] 301301 0
12 months of age

Eligibility
Key inclusion criteria
12-22 weeks gestation
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to attend monthly study visits, inability to perform manoeuvres required for spirometry or FENO, drug or alcohol dependence, unknown dates, chronic oral steroid use or use of immunosuppressant therapy.

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)
Allocation concealed by blinded randomisation list held by independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number list stratified by study centre and maternal smoking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2013
Actual
7/03/2013
Date of last participant enrolment
Anticipated
31/12/2019
Actual
11/06/2019
Date of last data collection
Anticipated
31/01/2020
Actual
28/01/2020
Sample size
Target
1200
Accrual to date
Final
1200
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 409 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 410 0
The Maitland Hospital - Maitland
Recruitment hospital [3] 411 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 412 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 413 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 414 0
Royal Hospital for Women - Randwick
Recruitment hospital [7] 6432 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 5841 0
2031
Recruitment postcode(s) [2] 5838 0
2065
Recruitment postcode(s) [3] 5836 0
2305
Recruitment postcode(s) [4] 5837 0
2320
Recruitment postcode(s) [5] 13977 0
2605 - Garran
Recruitment postcode(s) [6] 5839 0
2747
Recruitment postcode(s) [7] 5840 0
4029

Funding & Sponsors
Funding source category [1] 286152 0
Government body
Name [1] 286152 0
National Health and Medical Research Council (application ID 1060983)
Country [1] 286152 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital (Hunter New England Local Health District)
Address
Locked Bag 1,
HRMC
Newcastle NSW 2310
Country
Australia
Secondary sponsor category [1] 284960 0
Individual
Name [1] 284960 0
Prof Peter Gibson
Address [1] 284960 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing,
Hunter Medical Research Institute
Locked Bag 1, HRMC
Newcastle NSW 2310
Country [1] 284960 0
Australia
Other collaborator category [1] 277125 0
University
Name [1] 277125 0
University of Newcastle
Address [1] 277125 0
University Drive
Callaghan NSW 2308
Country [1] 277125 0
Australia
Other collaborator category [2] 277126 0
Hospital
Name [2] 277126 0
The Maitland Hospital
Address [2] 277126 0
550-560 High Street
Maitland NSW 2320
Country [2] 277126 0
Australia
Other collaborator category [3] 277127 0
Hospital
Name [3] 277127 0
Royal Hospital for Women, Randwick
Address [3] 277127 0
Barker Street
Randwick NSW 2031
Country [3] 277127 0
Australia
Other collaborator category [4] 277128 0
Hospital
Name [4] 277128 0
Royal North Shore Hospital
Address [4] 277128 0
Pacific Highway
St Leonards NSW 2065
Country [4] 277128 0
Australia
Other collaborator category [5] 277129 0
Hospital
Name [5] 277129 0
Royal Brisbane and Women's Hospital
Address [5] 277129 0
Cnr Butterfield St and Bowen Bridge Rd
Herston Qld 4029
Country [5] 277129 0
Australia
Other collaborator category [6] 277130 0
Hospital
Name [6] 277130 0
Nepean Hospital
Address [6] 277130 0
Derby Street
Kingswood NSW 2747
Country [6] 277130 0
Australia
Other collaborator category [7] 279155 0
Hospital
Name [7] 279155 0
The Canberra Hospital
Address [7] 279155 0
Yamba Dr, Garran
ACT 2605
Country [7] 279155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288623 0
Hunter New England Health Research Ethics Committee
Ethics committee address [1] 288623 0
Locked Bag 1
New Lambton
NSW 2305
Ethics committee country [1] 288623 0
Australia
Date submitted for ethics approval [1] 288623 0
Approval date [1] 288623 0
24/10/2012
Ethics approval number [1] 288623 0
12/10/17/3.04
Ethics committee name [2] 295676 0
ACT Health Human Research Ethics Committee
Ethics committee address [2] 295676 0
Building 10, Level 6
Canberra Hospital
PO Box 11, Woden ACT 2606
Ethics committee country [2] 295676 0
Australia
Date submitted for ethics approval [2] 295676 0
Approval date [2] 295676 0
10/12/2015
Ethics approval number [2] 295676 0
ETH.11.15.232

Summary
Brief summary
This study in pregnant women with asthma investigates the maternal, infant and childhood outcomes following asthma treatment adjustment using FENO, compared to standardised usual care treatment adjustment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34832 0
Prof Peter Gibson
Address 34832 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing
Hunter Medical Research Institute
Locked Bag 1,
HRMC
Newcastle NSW 2310
Country 34832 0
Australia
Phone 34832 0
61 02 40420143
Fax 34832 0
61 02 40420046
Email 34832 0
peter.gibson@hnehealth.nsw.gov.au
Contact person for public queries
Name 18079 0
Prof Prof Peter Gibson
Address 18079 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing
Hunter Medical Research Institute
Locked Bag 1,
HRMC
Newcastle NSW 2310
Country 18079 0
Australia
Phone 18079 0
61 02 40420143
Fax 18079 0
61 02 40420046
Email 18079 0
peter.gibson@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 9007 0
Prof Prof Peter Gibson
Address 9007 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing
Hunter Medical Research Institute
Locked Bag 1,
HRMC
Newcastle NSW 2310
Country 9007 0
Australia
Phone 9007 0
61 02 40420143
Fax 9007 0
61 02 40420046
Email 9007 0
peter.gibson@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have selected no at this time, but may change to yes in the future


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  vanessa.murphy@newcastle.edu.au
Study protocol  vanessa.murphy@newcastle.edu.au


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInterventions for managing asthma in pregnancy.2014https://dx.doi.org/10.1002/14651858.CD010660.pub2
EmbaseEffect of asthma management with exhaled nitric oxide versus usual care on perinatal outcomes.2022https://dx.doi.org/10.1183/13993003.00298-2022
EmbaseHigher exhaled nitric oxide at 6 weeks of age is associated with less bronchiolitis and wheeze in the first 12 months of age.2022https://dx.doi.org/10.1136/thoraxjnl-2021-217299
EmbaseObservational study of mental health in asthmatic women during the prenatal and postnatal periods.2020https://dx.doi.org/10.1080/02770903.2019.1621888
N.B. These documents automatically identified may not have been verified by the study sponsor.