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Year : 2013  |  Volume : 2  |  Issue : 2  |  Page : 73-75

Oxygen saturation and outcomes in preterm infants the boost ii United Kingdom, Australia, and New Zealand collaborative groups

Emad Khadawardi, Fahad Al Hazzani
Department of Pediatrics, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia

Correspondence Address:
Emad Khadawardi
Department of Pediatrics, King Faisal Specialist Hospital and Research Centre, Riyadh
Saudi Arabia

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/2249-4847.116404

Context

Materials and Methods

• The BOOST II collaborative groups conducted three international randomized, controlled trials in the UK, Australia, and New Zealand from March 2006 to December 2010
• The planned study sample size was 1200 infants each for UK and Australian trial and 340 infants for the New Zealand trial
• The short-term outcomes were reported on May 2013.
• Long-term outcomes (at 2 years) are not reported yet.

• Infant unlikely to survive
• Major congenital abnormality
• Infant would not be available for follow-up.

• Infants were randomly assigned to treatment with the use of an oxygen-saturation target of 85-89% (lower target group) or 91-95% (higher target group)
• To mask the intervention, the study oximeters were modified internally so that readings of 85-95% showed oxygen saturation that was either 3 percentage points higher or 3 percentage points lower than the actual value.
• To achieve the intended oxygen-saturation range in either group, clinical staff members targeted displayed readings in the range of 88-92%
• Only study oximeters were used from the time of randomization until 36 weeks, unless infants died or were discharged home
• Approximately halfway through the trials, between December 2008 and May 2009, oximeters in the United Kingdom and Australian trials were changed to the new calibration algorithm, and the new algorithm was used for all infants who were subsequently enrolled. The New Zealand trial oximeters were not changed because recruitment had nearly finished.

• Death
• Severe neurosensory disability at 18 months to 2 years of age, corrected for prematurity.

• Retinopathy of prematurity
• NEC
• Intraventricular hemorrhage
• Patent ductus arteriosus
• Bronchopulmonary dysplasia.

• Randomization was performed centrally by computer and separately for each trial
• In the United Kingdom, a minimization procedure was used to balance study-group assignment according to sex, gestational age, and center
• In Australia and New Zealand, randomization was stratified according to sex, gestational age, center, single birth or multiple births, and whether birth took place in the hospital where enrolment took place.

Results

• During the trials, investigators in the United Kingdom found that standard Masimo Radical oximeters returned fewer oxygen-saturation values in the range of 870-90% than expected. This reduced the frequency of displayed oxygen-saturation values ranging from 87% to 90% and caused values ranging from 87% to 96% to read 1-2% higher
• Masimo supplied software with a revised calibration algorithm
• A total of 2448 infants were enrolled in the three trials (973 in the United Kingdom, 1135 in Australia, and 340 in New Zealand)
• Of these infants, 1261 (51.5%) were treated with the use of the original oximeter-calibration algorithm and 1187 (48.5%) with the use of the revised algorithm
• Baseline demographic and clinical characteristics were similar in the two target groups, among the three trials, and in the two algorithm groups.

• The current publication reported the outcome for all infants until hospital discharge. The rate of long-term neurodevelopmental disability is expected to be published later
• Among the 1187 infants for whom the revised oximeter-calibration algorithm was used, those in the lower-target group had a higher rate of death than those in the higher-target group before hospital discharge [Table 1] and [Table 2], hence the trial was stopped early
• Among the 1261 infants for whom the original oximeter-calibration algorithm was used, there were no significant between group differences in outcomes at hospital discharge
• In all data combined, there was no significant difference in rate of death in the lower target group, as compared with the higher target group
• There were more deaths in the lower target group, but no single cause dominated the difference.

Table 1: Death before hospital discharge Click here to view

Table 2: Subgroup analysis by oximeter software Click here to view

• Infants in the lower target group had a reduced rate of treatment for retinopathy of prematurity
• Infants in the lower target group had an increased rate of NEC requiring surgery or causing death
• Fewer infants in the lower target group were treated with oxygen at 36 weeks in the three trials
• There was no significant difference in the rate of BPD, PDA, IVH and other brain injury between the two groups.

Commentary

References

1.	Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, et al. BOOST II United Kingdom Collaborative Group, BOOST II Australia Collaborative Group, BOOST II New Zealand Collaborative Group. Oxygen saturation and outcomes in preterm infants. N Engl J Med 2013;368:2094-104.
2.	Johnston ED, Boyle B, Juszczak E, King A, Brocklehurst P, Stenson BJ. Oxygen targeting in preterm infants using the Masimo SET Radical pulse oximeters. Arch Dis Child Fetal Neonatal Ed 2011;96:F429-33.
3.	Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, et al. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med 2010;362:1959-69.
4.	Schmidt B, Whyte RK, Asztalos EV, Moddemann D, Poets C, Rabi Y, et al. Canadian Oxygen Trial (COT) Group. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: A randomized clinical trial. JAMA 2013;309:2111-20.
5.	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;11:6.
6.	Polin RA, Bateman D. Oxygen-saturation targets in preterm infants. N Engl J Med 2013;368:1949-50.

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