The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?
Oxygen has been used in the care of small and sick newborn babies for over 60 years. However, to date there has been no reliable evidence to guide clinicians regarding what is the best level to target oxygen saturation in preterm infants to balance the four competing risks of mortality, lung disease, eye damage and developmental disability. Five high quality randomised controlled trials are now underway assessing two different levels of oxygen saturation targeting (USA - SUPPORT; Australia - BOOST II; New Zealand - BOOST NZ; UK - BOOST II UK; Canada - COT). The value of these gold-standard trials can be further enhanced when, with careful planning, they are synthesised into a prospective meta-analysis (PMA). A PMA is one where trials are identified for inclusion in the analysis before any of the individual results are known. We have established the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration, comprising the investigators of these five trials and a methodology team. The trials are sufficiently similar with respect to design, participants and intervention and, with planning, will have enough common outcome measures to enable their results to be prospectively meta-analysed. Together they have a combined sample size of almost 5000 enrolled infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,965
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Royal Prince Alfred Hospital Women and Babies
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Royal North Shore Hospital, NSW
St Leonards, New South Wales, Australia
Westmead Hospital,
Westmead, New South Wales, Australia
Royal Brisbane Women's Hospital
Brisbane, Queensland, Australia
Royal Women's Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
composite outcome of death or major disability by 18-24 months corrected age
Major disability is defined as any of the following: * Bayley-III Developmental Assessment cognitive score \<85 and/or language score \<85 * Severe visual loss * Cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher at 18-24 months postmenstrual age * Deafness requiring hearing aids
Time frame: by 18-24 months corrected age (gestational age plus chronological age)
Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection
Time frame: at 18-24 months corrected age
measures of respiratory support
• Measures of respiratory support, including the following separate outcomes a. supplemental oxygen requirement at 36 weeks postmenstrual age, b. postmenstrual age ceased endotracheal intubation, c. postmenstrual age ceased continuous positive airway pressure (CPAP), d. postmenstrual age ceased supplemental oxygen, e. postmenstrual age ceased home oxygen (if received).
Time frame: 36 weeks postmenstrual age
Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment
Time frame: at 18-24 months corrected age
Patent ductus arteriosus receiving surgical treatment
Time frame: at 18-24 months corrected age
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Time frame: 18-24 months corrected age
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Time frame: at 36 weeks' postmenstrual age and discharge home
Re-admissions to hospital
Time frame: up to 18-24 months postmenstrual age
Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age
Time frame: at 18-24 months corrected age
Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial)
Time frame: at 18-24 months corrected age
deafness requiring hearing aids
Time frame: at 18-24 months corrected age
Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
Time frame: 2 years corrected age
death
Time frame: at 18-24 months corrected age
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