An interventional study of Higher oxygen saturation target range (91%-95%) and Lower oxygen saturation (85%-89%) in Infant, Premature, Diseases, Bronchopulmonary Dysplasia and Retinopathy of Prematurity, sponsored by University of Sydney. Completed at 9 sites in Australia. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by University of Sydney · Not applicable, Interventional, and Treatment
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's enrollment of 4,965 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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%)
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%)
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
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
Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes.
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
Time frame: at 18-24 months corrected age
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Sydney