NeOProM: Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
Study Details
Study Description
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)?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Oxygen saturation Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. |
Procedure: Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
|
| Active Comparator: Lower oxygen saturation Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. |
Procedure: Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
|
Outcome Measures
Primary Outcome Measures
- 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
- Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection [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) [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]
Other Outcome Measures
- Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes. [at 18-24 months corrected age]
Subgroups: Gestational age less than 26 weeks greater than or equal to 26 weeks Inborn or outborn Use of any antenatal corticosteroids = yes if any of the following incomplete, less than 24 hours before birth complete more than 7 days before birth started less than 24h before birth started 24h or more before birth Male or female gender Small for gestation age birth weight below trialist defined cut-point birth weight less than 10th percentile using WHO centile charts Multiple or singleton birth Mode of delivery Vaginal if any of the following: vaginal, vaginal-cephalic, vaginal-breech Caesarean if any of the following: caesarean, caesarean section before onset of labour, caesarean section after onset of labour, caesarean section Time of intervention commencement less than 6 hours after birth 6 hours or more after birth Oximeter calibration software original revised
Eligibility Criteria
Criteria
Inclusion Criteria:
- Infants < 28wks gestation
Exclusion Criteria:
- Infants > 28wks gestation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Canberra Hospital | Canberra | Australian Capital Territory | Australia | |
| 2 | Royal Prince Alfred Hospital Women and Babies | Camperdown | New South Wales | Australia | 2050 |
| 3 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
| 4 | John Hunter Hospital | New Lambton | New South Wales | Australia | 2310 |
| 5 | Royal North Shore Hospital, NSW | St Leonards | New South Wales | Australia | |
| 6 | Westmead Hospital, | Westmead | New South Wales | Australia | 2145 |
| 7 | Royal Brisbane Women's Hospital | Brisbane | Queensland | Australia | 4006 |
| 8 | Royal Women's Hospital | Melbourne | Victoria | Australia | 3052 |
| 9 | Monash Medical Centre | Melbourne | Victoria | Australia | 3800 |
Sponsors and Collaborators
- University of Sydney
- University of Otago
- University of Oxford
- University of Pennsylvania
- University of California, San Diego
Investigators
- Principal Investigator: Lisa Askie, National Health and Medical Research Council, Australia
Study Documents (Full-Text)
None provided.More Information
Publications
- NeOProM