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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
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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.
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Secondary ID [1]
259747
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
BOOST-NZ
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Linked study record
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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
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Condition category
Condition code
Reproductive Health and Childbirth
393
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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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%.
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Intervention code [1]
240
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Treatment: Other
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Comparator / control treatment
Control group is oxygen saturation target of 91%-95%
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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Death or major disability
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Assessment method [1]
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Timepoint [1]
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At 2 years of age corrected for gestation at birth
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Secondary outcome [1]
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Severe retinopathy of prematurity subjected to retinal surgery - eyes assessed by indirect ophthalmoscopy and treatment given when Type 1 disease identified
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Assessment method [1]
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Timepoint [1]
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By one year of age
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Secondary outcome [2]
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Growth: Weight, length and head circumference at birth, hospital discharge and 2 years of age
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Assessment method [2]
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Timepoint [2]
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At 2 years old corrected for gestation at birth
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Secondary outcome [3]
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Cerebral palsy as assesed by paediatric examination
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Assessment method [3]
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Timepoint [3]
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At 2 years old corrected for gestation at birth
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Secondary outcome [4]
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Duration of oxygen therapy
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Assessment method [4]
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Timepoint [4]
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At 2 years of age corrected for gestation at birth
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Secondary outcome [5]
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Duration of use of positive airway respiratory support - endotracheal ventilation or nasal CPAP.
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Assessment method [5]
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0
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Timepoint [5]
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At 2 years of age corrected for gestation at birth
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Secondary outcome [6]
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Patent ductus arteriosus
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Assessment method [6]
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Timepoint [6]
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Hospital discharge for primary admission
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Secondary outcome [7]
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Mean Bayley III developmental assessment cognitive score
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Assessment method [7]
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Timepoint [7]
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At 2 years of age corrected for gestational age
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Secondary outcome [8]
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Necrotising enterocolitis requiring surgery
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Assessment method [8]
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Timepoint [8]
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Hospital discharge for primary admission
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Secondary outcome [9]
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Re-admissions to hospital before 24 months of age corrected for gestation
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Assessment method [9]
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0
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Timepoint [9]
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At 2 years of age corrected for gestation
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Secondary outcome [10]
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Death
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Assessment method [10]
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Timepoint [10]
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At 2 years of age corrected for gestation
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Eligibility
Key inclusion criteria
Less than 28 weeks gestation; less than 24 hours of age; signed parental consent.
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Minimum age
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Days
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Maximum age
1
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Congenital anomaly affecting oxygenation; clearly will be unable to follow up.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation ny phone
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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..
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2006
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Actual
15/09/2006
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Date of last participant enrolment
Anticipated
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Actual
5/12/2009
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
320
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
146
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New Zealand
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State/province [1]
146
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Funding & Sponsors
Funding source category [1]
445
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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PO Box 5541, Wellesley Street, Auckland 1141, New Zealand
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Country [1]
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New Zealand
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Cure Kids
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Address [2]
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Laundry Building
Suite 4, Level 4
58 Surrey Cresent
Grey Lynn
Auckland 1021
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Country [2]
287303
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
Christchurch School of Medicine
University of Otago Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
362
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Country [1]
362
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Multi-region Ethics Committee of the NZ Ministry of Health
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Ethics committee address [1]
1418
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Multi-region Ethics Committee
Ministry of Health
PO Box 5013
Wellington 6011
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Ethics committee country [1]
1418
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New Zealand
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Date submitted for ethics approval [1]
1418
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Approval date [1]
1418
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15/08/2005
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Ethics approval number [1]
1418
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MEC/05/06/067
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Brian Darlow
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Address
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Department of Paediatrics, University of Otago Christchurch,
PO Box 4345, Christchurch 8140
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Country
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New Zealand
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Phone
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+64 3 3640747
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Professor Brian Darlow
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Address
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Department of Paediatrics Christchurch School of Medicine University of Otago PO Box 4345 Christchurch 8140
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Country
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New Zealand
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Phone
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+64 3 3640747
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Professor Brian Darlow
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Address
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Department of Paediatrics Christchurch School of Medicine University of Otago PO Box 4345 Christchurch 8140
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Country
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New Zealand
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Phone
357
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+64 3 3640747
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Increased 36-Week Survival with High Oxygen Saturation Target in Extremely Preterm Infants
2011
https://doi.org/10.1056/nejmc1101319
Dimensions AI
NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol
2011
https://doi.org/10.1186/1471-2431-11-6
N.B. These documents automatically identified may not have been verified by the study sponsor.
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