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Clinical Trial
. 2015 Jan 5:350:g7635.
doi: 10.1136/bmj.g7635.

Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

Simon Hyttel-Sorensen  1 , Adelina Pellicer  2 , Thomas Alderliesten  3 , Topun Austin  4 , Frank van Bel  3 , Manon Benders  5 , Olivier Claris  6 , Eugene Dempsey  7 , Axel R Franz  8 , Monica Fumagalli  9 , Christian Gluud  10 , Berit Grevstad  11 , Cornelia Hagmann  12 , Petra Lemmers  3 , Wim van Oeveren  13 , Gerhard Pichler  14 , Anne Mette Plomgaard  1 , Joan Riera  15 , Laura Sanchez  2 , Per Winkel  10 , Martin Wolf  16 , Gorm Greisen  1
Affiliations
Clinical Trial

Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

Simon Hyttel-Sorensen et al. BMJ. .

Abstract

Objective: To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry.

Design: Phase II randomised, single blinded, parallel clinical trial.

Setting: Eight tertiary neonatal intensive care units in eight European countries.

Participants: 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support.

Interventions: Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).

Main outcome measures: The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography.

Randomisation: Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥ 26 weeks).

Blinding: Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation.

Results: The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device.

Conclusions: Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring.Trial registration ClinicalTrial.gov NCT01590316.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Schematic illustration of concept of burden of hypoxia and hyperoxia and the alarm. rStO2=regional tissue haemoglobin oxygen saturation
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Fig 2 Flow of participants through study. NIRS=cerebral near infrared spectroscopy oximetry
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Fig 3 Burden of hypoxia and hyperoxia by treatment group. NIRS=cerebral near infrared spectroscopy oximetry
See this image and copyright information in PMC

References

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