Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
- Conditions
- Infant, Newborn, DiseasesInfant, Premature, DiseasesBronchopulmonary DysplasiaRetinopathy of PrematurityInfant, Very Low Birth Weight
- Interventions
- Procedure: Higher oxygen saturation target range (91%-95%)Procedure: Lower oxygen saturation (85%-89%)
- Registration Number
- NCT01124331
- Lead Sponsor
- University of Sydney
- Brief Summary
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)?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4965
- Infants < 28wks gestation
- Infants > 28wks gestation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Oxygen saturation Higher oxygen saturation target range (91%-95%) Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. Lower oxygen saturation Lower oxygen saturation (85%-89%) Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.
- Primary Outcome Measures
Name Time Method composite outcome of death or major disability by 18-24 months corrected age by 18-24 months corrected age (gestational age plus chronological 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
- Secondary Outcome Measures
Name Time Method Re-admissions to hospital up to 18-24 months postmenstrual age deafness requiring hearing aids at 18-24 months corrected age Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection at 18-24 months corrected age death at 18-24 months corrected age measures of respiratory support 36 weeks postmenstrual age • 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).
Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment at 18-24 months corrected age Patent ductus arteriosus receiving surgical treatment at 18-24 months corrected age Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006) at 36 weeks' postmenstrual age and discharge home Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial) at 18-24 months corrected age Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age at 18-24 months corrected age Bayley-III Developmental Assessment cognitive score <85 and/or language score <85 2 years corrected age
Trial Locations
- Locations (9)
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Royal Prince Alfred Hospital Women and Babies
🇦🇺Camperdown, 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 Women's Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Brisbane Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia