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

University of Sydney

Status: Completed

Conditions: Infant, Premature, Diseases; Retinopathy of Prematurity; Infant, Very Low Birth Weight; Bronchopulmonary Dysplasia; Infant, Newborn, Diseases

Treatments: Procedure: Higher oxygen saturation target range (91%-95%); Procedure: Lower oxygen saturation (85%-89%)

Study type: Interventional

Funder types: Other

Identifiers

NCT01124331

NeOProM

Details and patient eligibility

About

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)?

Full 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.

Enrollment: 4,965 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants < 28wks gestation

Exclusion criteria

• Infants > 28wks gestation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,965 participants in 2 patient groups

High Oxygen saturation

Experimental group

Description:

Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.

Treatment:

Procedure: Higher oxygen saturation target range (91%-95%)

Lower oxygen saturation

Active Comparator group

Description:

Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.

Treatment:

Procedure: Lower oxygen saturation (85%-89%)