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Trial registered on ANZCTR


Trial ID
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
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
Address [1] 445 0
PO Box 5541, Wellesley Street, Auckland 1141, New Zealand
Country [1] 445 0
New Zealand
Funding source category [2] 287303 0
Charities/Societies/Foundations
Name [2] 287303 0
Cure Kids
Address [2] 287303 0
Laundry Building
Suite 4, Level 4
58 Surrey Cresent
Grey Lynn
Auckland 1021
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
Multi-region Ethics Committee
Ministry of Health
PO Box 5013
Wellington 6011
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
Oxygen is the commonest neonatal therapy. Unfortunately, both too much and too little oxygen may be harmful for very premature infants. We now measure the oxygen in a baby's blood by oxygen saturation but the optimum range in the first few weeks is unknown and no randomised controlled trial (RCT) has addressed this question. This proposal is for a New Zealand arm of a major international study involving 5000 babies, born at less than 28 weeks, to address this question. Babies will be randomised to a higher or lower target range of oxygen saturation from birth (85-89% or 91-95%). For all oximeters staff will target a masked range of 88-92%. We will assess which of the two target ranges is associated with the best overall outcome, which is a composite measure of survival, disability on a standard test of neurodevelopment (Bayley scales), and visual function at 2 years of age.
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
Prof 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
Prof 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