Trial reportActa paediatrica (Oslo, Norway : 1992)2019
No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life.
Trial report in Acta paediatrica (Oslo, Norway : 1992), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 63 citations in OpenAlex.
- Tissue Oxygenation Changes After Transfusion and Outcomes in Preterm Infants: A Secondary Near-Infrared Spectroscopy Study of the Transfusion of Prematures Randomized Clinical Trial (TOP NIRS).JAMA network open · 2023Trial
- Trial
- Cerebral oxygen saturation and autoregulation during hypotension in extremely preterm infants.Pediatric research · 2021Trial
- Prolonged cerebral oxygenation surveillance with algorithm-based management: a neurocritical care bundle for extremely preterm infants.Clinical and experimental pediatrics · 2026Article
- Associations between postnatal cerebral oxygen availability and utilization in very to late preterm infants and neurodevelopmental outcome.Scientific reports · 2026Observational
- Article
- Measuring cerebral hemodynamics and oxygen metabolism indices using NIR-TRS in premature infants from birth to term-equivalent age.Scientific reports · 2025Article
- Near-infrared spectroscopy monitoring of neonatal cerebrovascular reactivity: where are we now?Pediatric research · 2024Review
- The SafeBoosC-III trial and the future of cerebral oximetry-guided interventions in preterm infants-time to pause and reset?Translational pediatrics · 2024Article
- An Update on Pharmacologic Management of Neonatal Hypotension: When, Why, and Which Medication.Children (Basel, Switzerland) · 2024Review
- Neurodevelopmental and behavioral outcomes of very preterm infants: latent profile analysis in the Environmental influences on Child Health Outcomes (ECHO) Program.Pediatric research · 2024Article
- Early EEG-burst sharpness and 2-year disability in extremely preterm infants.Pediatric research · 2024Article
- Monitoring and evaluation of hypotension in the extremely preterm.Frontiers in cardiovascular medicine · 2024Review
- Article
- Neuromonitoring in neonatal critical care part II: extremely premature infants and critically ill neonates.Pediatric research · 2023Review
- Machine Learning Detects Intraventricular Haemorrhage in Extremely Preterm Infants.Children (Basel, Switzerland) · 2023Article
- Associations between neurological examination at term-equivalent age and cerebral hemodynamics and oxygen metabolism in infants born preterm.Frontiers in neuroscience · 2023Article
- Assessing cerebral blood flow, oxygenation and cytochrome c oxidase stability in preterm infants during the first 3 days after birth.Scientific reports · 2022Article
- Three Physiological Components That Influence Regional Cerebral Tissue Oxygen Saturation.Frontiers in pediatrics · 2022Article
- Cerebral Oxygenation and Metabolism After Hypoxia-Ischemia.Frontiers in pediatrics · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 7 countries.
Funding
Abstract
aimCerebral hypoxia has been associated with neurodevelopmental impairment. We studied whether reducing cerebral hypoxia in extremely preterm infants during the first 72 hours of life affected neurological outcomes at two years of corrected age.
methodsIn 2012-2013, the phase II randomised Safeguarding the Brains of our smallest Children trial compared visible cerebral near-infrared spectroscopy (NIRS) monitoring in an intervention group and blinded NIRS monitoring in a control group. Cerebral hypoxia was significantly reduced in the intervention group. We followed up 115 survivors from eight European centres at two years of corrected age, by conducting a medical examination and assessing their neurodevelopment with the Bayley Scales of Infant and Toddler Development, Second or Third Edition, and the parental Ages and Stages Questionnaire (ASQ).
resultsThere were no differences between the intervention (n = 65) and control (n = 50) groups with regard to the mean mental developmental index (89.6 ± 19.5 versus 88.4 ± 14.7, p = 0.77), ASQ score (215 ± 58 versus 213 ± 58, p = 0.88) and the number of children with moderate-to-severe neurodevelopmental impairment (10 versus six, p = 0.58).
conclusionCerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age.
Indexed as
Identifiers
What OpenQuestion holds
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.