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Study protocol
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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 randomized, pragmatic phase III clinical trial. It is open label, but parts will be conducted blinded to intervention. Inclusion criteria consists of infants born below 28 weeks postmenstrual age and parental informed consent (unless the site has is using ‘opt-out’ or deferred consent). Exclusion criteria consists of missing parental informed consent (or if ‘opt-out’ is used, lack of record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record in the infant’s clinical file of parents’ decision to opt-out); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 hours after birth. Participants will be randomized 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 hours 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. To detect a 22% relative risk difference between the experimental and control group, we intend to randomize a cohort of 1600 infant.
Discussion
Treatment guided by cerebral NIRS oximetry has the potential to decrease 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.
Keywords
Randomized clinical trial; preterm; near infrared spectroscopy; protocol
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 22 Nov, 2019
Review #2 received
Received 21 Nov, 2019
Reviewer #1 agreed
On 06 Nov, 2019
Reviewer #2 agreed
On 06 Nov, 2019
Review #1 received
Received 06 Nov, 2019
Reviewers invited
Invitations sent on 03 Nov, 2019
Editor assigned
On 02 Nov, 2019
Submission checks complete
On 01 Nov, 2019
Version 1
Posted 25 Mar, 2019
No comments provided
Review #2 received
Received 09 Oct, 2019
Editorial decision: Minor revision
On 09 Oct, 2019
Reviewer #2 agreed
On 20 Sep, 2019
Review #1 received
Received 27 Aug, 2019
Reviewer #1 agreed
On 26 Aug, 2019
Reviewers invited
Invitations sent on 22 Aug, 2019
Editor assigned
On 11 May, 2019
Submission checks complete
On 21 Mar, 2019
First submitted
On 22 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 22 Nov, 2019
Review #2 received
Received 21 Nov, 2019
Reviewer #1 agreed
On 06 Nov, 2019
Reviewer #2 agreed
On 06 Nov, 2019
Review #1 received
Received 06 Nov, 2019
Reviewers invited
Invitations sent on 03 Nov, 2019
Editor assigned
On 02 Nov, 2019
Submission checks complete
On 01 Nov, 2019
Version 1
Posted 25 Mar, 2019
No comments provided
Review #2 received
Received 09 Oct, 2019
Editorial decision: Minor revision
On 09 Oct, 2019
Reviewer #2 agreed
On 20 Sep, 2019
Review #1 received
Received 27 Aug, 2019
Reviewer #1 agreed
On 26 Aug, 2019
Reviewers invited
Invitations sent on 22 Aug, 2019
Editor assigned
On 11 May, 2019
Submission checks complete
On 21 Mar, 2019
First submitted
On 22 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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 randomized, pragmatic phase III clinical trial. It is open label, but parts will be conducted blinded to intervention. Inclusion criteria consists of infants born below 28 weeks postmenstrual age and parental informed consent (unless the site has is using ‘opt-out’ or deferred consent). Exclusion criteria consists of missing parental informed consent (or if ‘opt-out’ is used, lack of record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record in the infant’s clinical file of parents’ decision to opt-out); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 hours after birth. Participants will be randomized 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 hours 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. To detect a 22% relative risk difference between the experimental and control group, we intend to randomize a cohort of 1600 infant.
Discussion
Treatment guided by cerebral NIRS oximetry has the potential to decrease 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.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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