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| Name | Class |
|---|---|
| University of Otago | OTHER |
| University of Oxford | OTHER |
| University of Pennsylvania | OTHER |
| University of California, San Diego |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Oxygen saturation | Experimental | 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 | Active Comparator | Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher oxygen saturation target range (91%-95%) | Procedure | higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome of death or major disability by 18-24 months corrected age | Major disability is defined as any of the following:
| by 18-24 months corrected age (gestational age plus chronological age) |
| Measure | Description | Time Frame |
|---|---|---|
| Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes. | Subgroups:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Askie | National Health and Medical Research Council, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Canberra | Australian Capital Territory | Australia | |||
| Royal Prince Alfred Hospital Women and Babies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21235822 | Background | Askie LM, Brocklehurst P, Darlow BA, Finer N, Schmidt B, Tarnow-Mordi W; NeOProM Collaborative Group. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatr. 2011 Jan 17;11:6. doi: 10.1186/1471-2431-11-6. | |
| 29872859 | Result | Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, Davis PG, Carlo WA, Brocklehurst P, Davies LC, Das A, Rich W, Gantz MG, Roberts RS, Whyte RK, Costantini L, Poets C, Asztalos E, Battin M, Halliday HL, Marlow N, Tin W, King A, Juszczak E, Morley CJ, Doyle LW, Gebski V, Hunter KE, Simes RJ; Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA. 2018 Jun 5;319(21):2190-2201. doi: 10.1001/jama.2018.5725. |
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| OTHER |
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| Lower oxygen saturation (85%-89%) | Procedure | Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter |
|
| 36 weeks postmenstrual age |
| 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) | 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 |
| Re-admissions to hospital | 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 | 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) | at 18-24 months corrected age |
| deafness requiring hearing aids | at 18-24 months corrected age |
| Bayley-III Developmental Assessment cognitive score <85 and/or language score <85 | 2 years corrected age |
| death | at 18-24 months corrected age |
| at 18-24 months corrected age |
| Camperdown |
| New South Wales |
| 2050 |
| Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| John Hunter Hospital | New Lambton | New South Wales | 2310 | Australia |
| Royal North Shore Hospital, NSW | St Leonards | New South Wales | Australia |
| Westmead Hospital, | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane Women's Hospital | Brisbane | Queensland | 4006 | Australia |
| Royal Women's Hospital | Melbourne | Victoria | 3052 | Australia |
| Monash Medical Centre | Melbourne | Victoria | 3800 | Australia |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D001997 | Bronchopulmonary Dysplasia |
| D012178 | Retinopathy of Prematurity |
| D007232 | Infant, Newborn, Diseases |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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