Trial reportArchives of disease in childhood. Fetal and neonatal edition2016
The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01590316 (SafeBoosC - Safeguarding the Brain of Our Smallest Children - an Investigator-initiated Randomised, Blinded, Multinational, Phase II Feasibility Clinical Trial on Near-infrared Spectroscopy Monitoring Combined With Defined Treatment Guidelines Versus Standard Monitoring and Treatment as Usual in Premature Infants), which is not on this map. Cited by 15 papers.
What it found
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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.
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.
SafeBoosC - Safeguarding the Brain of Our Smallest Children - an Investigator-initiated Randomised, Blinded, Multinational, Phase II Feasibility Clinical Trial on Near-infrared Spectroscopy Monitoring Combined With Defined Treatment Guidelines Versus Standard Monitoring and Treatment as Usual in Premature Infants
Who cites it
15 citing papers in PubMed, 27 citations in OpenAlex.
- Late permissive hypercapnia and respiratory stability among very preterm infants: a pilot randomised trial.Archives of disease in childhood. Fetal and neonatal edition · 2023Trial
- Cerebral oxygenation monitoring in the delivery room - quo vadis?Pediatric research · 2026Article
- Cerebral oxygenation in the preterm newborn - what can we do?Pediatric research · 2024Article
- Cerebral near-infrared spectroscopy guided neonatal intensive care management for the preterm infant.Pediatric research · 2024Review
- Near-infrared spectroscopy monitoring of neonatal cerebrovascular reactivity: where are we now?Pediatric research · 2024Review
- Observational
- Carbon dioxide and brain injury in preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Comparison of INVOS 5100C and Nonin SenSmart X-100 oximeter performance in preterm infants with spontaneous apnea.Pediatric research · 2020Article
- Article
- Article
- Regional tissue oxygenation monitoring in the neonatal intensive care unit: evidence for clinical strategies and future directions.Pediatric research · 2019Review
- Simultaneous Near-Infrared Spectroscopy (NIRS) and Amplitude-Integrated Electroencephalography (aEEG): Dual Use of Brain Monitoring Techniques Improves Our Understanding of Physiology.Frontiers in pediatrics · 2019Article
- Postnatal Cerebral Hyperoxia Is Associated with an Increased Risk of Severe Retinopathy of Prematurity.Neonatology · 2019Article
- How to assess hemodynamic status in very preterm newborns in the first week of life?Journal of perinatology : official journal of the California Perinatal Association · 2017Review
- Cerebral oximetry in preterm infants: an agenda for research with a clear clinical goal.Neurophotonics · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 11 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe SafeBoosC phase II randomised clinical trial recently demonstrated the benefits of a combination of cerebral regional tissue oxygen saturation (rStO2) by near-infrared spectroscopy (NIRS) and a treatment guideline to reduce the oxygen imbalance in extremely preterm infants.
aimsTo analyse rStO2-alarm-related clinical decisions and their heterogeneity in the NIRS experimental group (NIRS monitoring visible) and their impact on rStO2 and SpO2.
methodsContinuous data from NIRS devices and the alarms (area under the curve of the rStO2 out of range had accumulated 0.2%h during 10 min), clinical data at discrete time points and interventions prompted by the alarms were recorded.
resultsSixty-seven infants had data that fulfilled the requirements for this analysis. 1107 alarm episodes were analysed. The alarm triggered a treatment guideline intervention in 25% of the cases; the type of intervention chosen varied among clinical sites. More than 55% of alarms were not followed by an intervention ('No action'); additionally, in 5% of alarms the rStO2 value apparently was considered non-reliable and the sensor was repositioned. The percentage of unresolved alarms at 30 min after 'No action' almost doubled the treatment guideline intervention (p<0.001). Changes in peripheral oxygen saturation (SpO2), were observed only after treatment guideline interventions.
conclusionsThis study shows that 25% of rStO2 alarms were followed by a clinical intervention determined by the treatment guideline. However, the rStO2 and SpO2 returned to normal ranges after the intervention, supporting the notion that decisions taken by the clinicians were appropriate. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov NCT01590316.
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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.