Trial reportPediatric research2016
Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments.
Trial report in Pediatric research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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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.
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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.
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Who cites it
18 citing papers in PubMed, 44 citations in OpenAlex.
- 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
- Trial
- No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life.Acta paediatrica (Oslo, Norway : 1992) · 2019Trial
- Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial.PloS one · 2017Trial
- Cerebral near-infrared spectroscopy guided neonatal intensive care management for the preterm infant.Pediatric research · 2024Review
- Article
- Early EEG-burst sharpness and 2-year disability in extremely preterm infants.Pediatric research · 2024Article
- Article
- Neuromonitoring in neonatal critical care part II: extremely premature infants and critically ill neonates.Pediatric research · 2023Review
- Association of early cerebral oxygen saturation and brain injury in extremely preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Three Physiological Components That Influence Regional Cerebral Tissue Oxygen Saturation.Frontiers in pediatrics · 2022Article
- Article
- Regional tissue oxygenation monitoring in the neonatal intensive care unit: evidence for clinical strategies and future directions.Pediatric research · 2019Review
- Future perspectives on the use of deformation analysis to identify the underlying pathophysiological basis for cardiovascular compromise in neonates.Pediatric research · 2019Review
- Is Supplemental Oxygen Needed in Cardiac Compression?-The Influence of Oxygen on Cerebral Perfusion in Severely Asphyxiated Neonates With Bradycardia or Cardiac Asystole.Frontiers in pediatrics · 2019Review
- Interpretation of Cerebral Oxygenation Changes in the Preterm Infant.Children (Basel, Switzerland) · 2018Review
- Early postnatal illness severity scores predict neurodevelopmental impairments at 10 years of age in children born extremely preterm.Journal of perinatology : official journal of the California Perinatal Association · 2017Observational
- Cerebral oximetry in preterm infants: an agenda for research with a clear clinical goal.Neurophotonics · 2016Article
Corrections and comments
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Authors and funding
16 authors at 10 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAbnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular hemorrhages and lower developmental score. In SafeBoosC II, we obtained a significant reduction of cerebral hypoxia by monitoring cerebral oxygenation in combination with a treatment guideline. Here, we describe (i) difference in brain injury between groups, (ii) feasibility of serial cranial ultrasound (cUS) and magnetic resonance imaging (MRI), (iii) local and central cUS assessment.
methodsHundred and sixty-six extremely preterm infants were included. cUS was scheduled for day 1, 4, 7, 14, and 35 and at term-equivalent age (TEA). cUS was assessed locally (unblinded) and centrally (blinded). MRI at TEA was assessed centrally (blinded). Brain injury classification: no, mild/moderate, or severe.
resultsSevere brain injury did not differ significantly between groups: cUS (experimental 10/80, control 18/77, P = 0.32) and MRI (5/46 vs. 3/38, P = 0.72). Kappa values for local and central readers were moderate-to-good for severe and poor-to-moderate for mild/moderate injuries. At TEA, cUS and MRI were assessed in 72 and 64%, respectively.
conclusionThere was no difference in severe brain injury between groups. Acquiring cUS and MRI according the standard operating procedures must be improved for future trials. Whether monitoring cerebral oxygenation during the first 72 h of life prevents brain injury should be evaluated in larger multicenter trials.
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