Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
NCT ID: NCT01124331
Last Updated: 2019-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
4965 participants
INTERVENTIONAL
2005-03-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
NCT07251790
Measuring Oxygenation of Newborn Infants in Targeted Oxygen Ranges
NCT03360292
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
NCT07101419
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
NCT03695900
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
NCT02743988
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
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.
Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
24 Hours
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Otago
OTHER
University of Oxford
OTHER
University of Pennsylvania
OTHER
University of California, San Diego
OTHER
University of Sydney
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lisa Askie
Role: PRINCIPAL_INVESTIGATOR
National Health and Medical Research Council, Australia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Royal Prince Alfred Hospital Women and Babies
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Royal North Shore Hospital, NSW
St Leonards, New South Wales, Australia
Westmead Hospital,
Westmead, New South Wales, Australia
Royal Brisbane Women's Hospital
Brisbane, Queensland, Australia
Royal Women's Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NeOProM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.