NCT01124331

Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,965 (actual)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Premature, Diseases
• Bronchopulmonary Dysplasia
• Retinopathy of Prematurity
• Infant, Newborn, Diseases
• Infant, Very Low Birth Weight

Interventions

Type	Name	Description
PROCEDURE	Higher oxygen saturation target range (91%-95%)	higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
PROCEDURE	Lower oxygen saturation (85%-89%)	Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter

Timeline

• Start date: 2005-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-05-17
• Last updated: 2019-03-13

Locations

9 sites across 1 country: Australia