ArticleTrials2019
Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safeguarding the Brain of Our Smallest Children - an Investigator-initiated, Pragmatic, Open Label, Multinational Randomized Phase IIIclinical Trial Evaluating Treatment Based on Near-infrared Spectroscopy Monitoring Versus Treatment as Usual in Premature Infants
Extremely Premature Births During the Peak of the COVID-19 Pandemic: an International Study of the Active SafeBoosC III Departments
Who cites it
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- Cerebral near-infrared spectroscopy monitoring (NIRS) in children and adults: a systematic review with meta-analysis.Pediatric research · 2024Pooled it
- Normal regional tissue oxygen saturation in neonates: a systematic qualitative review.Pediatric research · 2024Pooled it
- Optimising data completeness and quality in multicentre randomised clinical trials using central data monitoring: a pragmatic approach.BMC medical research methodology · 2026Trial
- Cerebral Oximetry in Extremely Preterm Infants: 2-Year Follow-Up of the SafeBoosC-III Randomized Clinical Trial.JAMA pediatrics · 2026Trial
- Trial
- Can non-pharmacological comfort care replace fentanyl in LISA? The NONA-LISA feasibility study.Pediatric research · 2026Trial
- Trial
- Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial.BMJ (Clinical research ed.) · 2023Trial
- Cerebral oxygen saturation and autoregulation during hypotension in extremely preterm infants.Pediatric research · 2021Trial
- Central data monitoring in the multicentre randomised SafeBoosC-III trial - a pragmatic approach.BMC medical research methodology · 2021Trial
- Article
- Review
- Near-infrared spectroscopy monitoring of neonatal cerebrovascular reactivity: where are we now?Pediatric research · 2024Review
- The Role of Oxidative Stress in the Progression of Secondary Brain Injury Following Germinal Matrix Hemorrhage.Translational stroke research · 2024Review
- Electrical Cardiometry during transition and short-term outcome in very preterm infants: a prospective observational study.European journal of pediatrics · 2024Observational
- Cerebral near-infrared spectroscopy for early recognition of impending cardiac tamponade in a preterm neonate.BMJ case reports · 2023Article
- Preterm Infants off Positive Pressure Respiratory Support Have a Higher Incidence of Occult Cerebral Hypoxia.The Journal of pediatrics · 2023Observational
- Cerebral oxygen saturation in neonates: a bedside comparison between neonatal and adult NIRS sensors.Pediatric research · 2023Observational
- Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors at 20 institutions in 19 countries.
Funding
Abstract
backgroundCerebral 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/
designSafeBoosC 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 registrationClinicalTrial.gov, NCT03770741. Registered 10 December 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.