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Trial registered on ANZCTR


Registration number
ACTRN12605000253606
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
1/09/2005
Date last updated
17/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
BOOST-NZ
Scientific title
A randomised phase III study to evaluate whether a lower versus a higher oxygen saturation target in infants of <28 weeks gestation is associated with a reduction in death or disability at 2 years of age.
Secondary ID [1] 259747 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BOOST-NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The role of oxygen saturation targetting in morbidity and mortality in infants born less than 28 weeks gestation 340 0
Condition category
Condition code
Reproductive Health and Childbirth 393 393 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants are randomised at less than 24 hours of age to an oxygen saturation target of 85%-89% or 91%-95%.
Intervention code [1] 240 0
Treatment: Other
Comparator / control treatment
Control group is oxygen saturation target of 91%-95%
Control group
Dose comparison

Outcomes
Primary outcome [1] 450 0
Death or major disability
Timepoint [1] 450 0
At 2 years of age corrected for gestation at birth
Secondary outcome [1] 986 0
Severe retinopathy of prematurity subjected to retinal surgery - eyes assessed by indirect ophthalmoscopy and treatment given when Type 1 disease identified
Timepoint [1] 986 0
By one year of age
Secondary outcome [2] 302845 0
Growth: Weight, length and head circumference at birth, hospital discharge and 2 years of age
Timepoint [2] 302845 0
At 2 years old corrected for gestation at birth
Secondary outcome [3] 302846 0
Cerebral palsy as assesed by paediatric examination
Timepoint [3] 302846 0
At 2 years old corrected for gestation at birth
Secondary outcome [4] 302847 0
Duration of oxygen therapy
Timepoint [4] 302847 0
At 2 years of age corrected for gestation at birth
Secondary outcome [5] 302848 0
Duration of use of positive airway respiratory support - endotracheal ventilation or nasal CPAP.
Timepoint [5] 302848 0
At 2 years of age corrected for gestation at birth
Secondary outcome [6] 302849 0
Patent ductus arteriosus
Timepoint [6] 302849 0
Hospital discharge for primary admission
Secondary outcome [7] 302850 0
Mean Bayley III developmental assessment cognitive score
Timepoint [7] 302850 0
At 2 years of age corrected for gestational age
Secondary outcome [8] 302851 0
Necrotising enterocolitis requiring surgery
Timepoint [8] 302851 0
Hospital discharge for primary admission
Secondary outcome [9] 302852 0
Re-admissions to hospital before 24 months of age corrected for gestation
Timepoint [9] 302852 0
At 2 years of age corrected for gestation
Secondary outcome [10] 302853 0
Death
Timepoint [10] 302853 0
At 2 years of age corrected for gestation

Eligibility
Key inclusion criteria
Less than 28 weeks gestation; less than 24 hours of age; signed parental consent.
Minimum age
0 Days
Maximum age
1 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital anomaly affecting oxygenation; clearly will be unable to follow up.

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)
Central Randomisation ny phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by hospital; less than 26 weeks gestation ot 26 weeks gestation or more with allocation by computer programme..
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2006
Actual
15/09/2006
Date of last participant enrolment
Anticipated
Actual
5/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment outside Australia
Country [1] 146 0
New Zealand
State/province [1] 146 0

Funding & Sponsors
Funding source category [1] 445 0
Government body
Name [1] 445 0
Health Research Council of New Zealand
Country [1] 445 0
New Zealand
Funding source category [2] 287303 0
Charities/Societies/Foundations
Name [2] 287303 0
Cure Kids
Country [2] 287303 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Christchurch School of Medicine
University of Otago Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 362 0
None
Name [1] 362 0
Nil
Address [1] 362 0
Country [1] 362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1418 0
Multi-region Ethics Committee of the NZ Ministry of Health
Ethics committee address [1] 1418 0
Ethics committee country [1] 1418 0
New Zealand
Date submitted for ethics approval [1] 1418 0
Approval date [1] 1418 0
15/08/2005
Ethics approval number [1] 1418 0
MEC/05/06/067

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

Contacts
Principal investigator
Name 35986 0
Prof Brian Darlow
Address 35986 0
Department of Paediatrics, University of Otago Christchurch,
PO Box 4345, Christchurch 8140
Country 35986 0
New Zealand
Phone 35986 0
+64 3 3640747
Fax 35986 0
Email 35986 0
brian.darlow@otago.ac.nz
Contact person for public queries
Name 9429 0
Professor Brian Darlow
Address 9429 0
Department of Paediatrics Christchurch School of Medicine University of Otago PO Box 4345 Christchurch 8140
Country 9429 0
New Zealand
Phone 9429 0
+64 3 3640747
Fax 9429 0
Email 9429 0
brian.darlow@chmeds.ac.nz
Contact person for scientific queries
Name 357 0
Professor Brian Darlow
Address 357 0
Department of Paediatrics Christchurch School of Medicine University of Otago PO Box 4345 Christchurch 8140
Country 357 0
New Zealand
Phone 357 0
+64 3 3640747
Fax 357 0
Email 357 0
brian.darlow@chmeds.ac.nz

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
Dimensions AIIncreased 36-Week Survival with High Oxygen Saturation Target in Extremely Preterm Infants2011https://doi.org/10.1056/nejmc1101319
Dimensions AINeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol2011https://doi.org/10.1186/1471-2431-11-6
N.B. These documents automatically identified may not have been verified by the study sponsor.