Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sydney
- Enrollment
- 4,965
- Locations
- 9
- Primary Endpoint
- composite outcome of death or major disability by 18-24 months corrected age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 24 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants < 28wks gestation
Exclusion Criteria
- •Infants > 28wks gestation
Arms & Interventions
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.
Intervention: Higher oxygen saturation target range (91%-95%) (Procedure)
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.
Intervention: Lower oxygen saturation (85%-89%) (Procedure)
Outcomes
Primary Outcomes
composite outcome of death or major disability by 18-24 months corrected age
Time Frame: 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 Outcomes
- death(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)
- measures of respiratory support(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)(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)
- Re-admissions to hospital(up to 18-24 months postmenstrual age)
- deafness requiring hearing aids(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)