ArticleTrials2026
Cerebral oximetry monitoring versus usual care for extremely preterm infants: a detailed statistical analysis plan for the 2-year follow-up of the participants of the SafeBoosC-III randomised clinical trial.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05134116 (Cerebral Near-infrared Spectroscopy Monitoring Versus Treatment as Usual for Extremely Preterm Infants), which is not on this map. Cited by 1 paper.
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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.
Cerebral Near-infrared Spectroscopy Monitoring Versus Treatment as Usual for Extremely Preterm Infants: a Protocol for the Follow-up Study for the SafeBoosC-III Trial
Who cites it
1 citing paper in PubMed.
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe SafeBoosC-III trial investigated treatment guided by cerebral oximetry monitoring for the first 72 h after birth in extremely preterm infants (born below 28 weeks gestational age) and showed no effects on mortality or severe brain injury at 36 weeks' postmenstrual age versus usual care. As severe brain injury in the neonatal period is not a strong predictor of long-term neurodevelopmental outcomes, the prospectively planned SafeBoosC-III follow-up study aims to assess the long-term benefits and harms of the experimental intervention versus usual care at 2 years of corrected age. The statistical analysis plan presented here was defined before data collection was complete and outlines our approach for analysing outcomes in the SafeBoosC-III follow-up study.
methodsThe co-primary outcomes were (1) a composite of death or moderate-to-severe neurodevelopmental disability and (2) the mean Bayley-III/IV cognitive score. We employed a 3-tier data model, incorporating routine clinical follow-up, parental questionnaires, and informal assessments to minimise missing data. All randomised participants with available data were included in all analyses. Mixed-effect linear and logistic regression was used to analyse the dichotomous and continuous co-primary outcomes, respectively. Sensitivity analyses were conducted to address missing data and assess the robustness of our findings. DISCUSSION: This statistical analysis plan aimed to ensure transparency and reduce the risk of outcome reporting bias. By including dichotomous and continuous co-primary outcomes, we aimed to provide a comprehensive evaluation of the intervention's effect on long-term benefits and harms.
trial registrationClinicalTrials.gov NCT05134116 . Registered on November 24, 2021.
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