Bronchopulmonary Dysplasia Clinical Trial
Official title:
Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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||
| Completed |
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||
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| Terminated |
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||
| Completed |
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| Unknown status |
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Phase 2/Phase 3 | |
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||
| Completed |
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|
Phase 2 | |
| Completed |
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|
N/A | |
| Completed |
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|
Phase 3 | |
| Terminated |
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|
N/A | |
| Completed |
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Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|
N/A | |
| Completed |
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| Completed |
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Phase 3 | |
| Completed |
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N/A | |
| Completed |
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||
| Recruiting |
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N/A |