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. 2019 Dec 30;20(1):811.
doi: 10.1186/s13063-019-3955-6.

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

Mathias Lühr Hansen  1 , Adelina Pellicer  2 , Christian Gluud  3 , Eugene Dempsey  4 , Jonathan Mintzer  5 , Simon Hyttel-Sørensen  6 , Anne Marie Heuchan  7 , Cornelia Hagmann  8 , Ebru Ergenekon  9 , Gabriel Dimitriou  10 , Gerhard Pichler  11 , Gunnar Naulaers  12 , Guoqiang Cheng  13 , Hercilia Guimarães  14 , Jakub Tkaczyk  15 , Karen B Kreutzer  16 , Monica Fumagalli  17   18 , Olivier Claris  19 , Petra Lemmers  20 , Siv Fredly  21 , Tomasz Szczapa  22 , Topun Austin  23 , Janus Christian Jakobsen  3   24   25 , Gorm Greisen  26
Affiliations

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

Mathias Lühr Hansen et al. Trials. .

Abstract

Background: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.

Methods/design: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.

Discussion: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.

Trial registration: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

Keywords: Near infrared spectroscopy; Preterm; Protocol; Randomised clinical trial.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schedule for enrolment, intervention and assessment, based on the SPIRIT 2013 guidance for protocols of clinical trials. *If approved by the local ethics committee, deferred informed consent or prior informed assent may be sought. Time to ask parents for deferred consent will be decided individually by clinical staff members
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