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

2014-08-27 03:13:40 | BioPortfolio

Summary

For over 60 years the most appropriate oxygen level for preterm babies remains unknown. To answer this, we will combine data from over 5300 babies to be sure the expected benefits of lower oxygen for babies' eyes and lungs does not come at the expense of increasing death or major disability in these children. Planning to do this before the results of any of the trials are known is called a prospective meta-analysis. This is the first time this technique has been used in neonatal medicine.

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 over 5,300 enrolled infants.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Infant, Premature

Intervention

Higher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)

Location

Canberra Hospital
Canberra
Australian Capital Territory
Australia
2050

Status

Recruiting

Source

University of Sydney

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:40-0400

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PubMed Articles [25523 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

The determination of oxygen-hemoglobin saturation of blood either by withdrawing a sample and passing it through a classical photoelectric oximeter or by electrodes attached to some translucent part of the body like finger, earlobe, or skin fold. It includes non-invasive oxygen monitoring by pulse oximetry.

The rate at which oxygen is used by a tissue; microliters of oxygen STPD used per milligram of tissue per hour; the rate at which oxygen enters the blood from alveolar gas, equal in the steady state to the consumption of oxygen by tissue metabolism throughout the body. (Stedman, 25th ed, p346)

A method for extinguishing anxiety by a saturation exposure to the feared stimulus situation or its substitute.

Stable oxygen atoms that have the same atomic number as the element oxygen, but differ in atomic weight. O-17 and 18 are stable oxygen isotopes.

Molecules or ions formed by the incomplete one-electron reduction of oxygen. These reactive oxygen intermediates include SINGLET OXYGEN; SUPEROXIDES; PEROXIDES; HYDROXYL RADICAL; and HYPOCHLOROUS ACID. They contribute to the microbicidal activity of PHAGOCYTES, regulation of signal transduction and gene expression, and the oxidative damage to NUCLEIC ACIDS; PROTEINS; and LIPIDS.

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