ArticleTrials2023
Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial.
Article in Trials, 2023. 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 5 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.
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
5 citing papers in PubMed, 9 citations in OpenAlex.
- Cerebral Oximetry in Extremely Preterm Infants: 2-Year Follow-Up of the SafeBoosC-III Randomized Clinical Trial.JAMA pediatrics · 2026Trial
- Article
- Cerebral near-infrared spectroscopy guided neonatal intensive care management for the preterm infant.Pediatric research · 2024Review
- Do Different Amounts of Exogenous Surfactant Differently Influence Cerebrovascular Instability in a Consecutive Group of Preterm Babies? Preliminary Results from a Single-Center Experience.Children (Basel, Switzerland) · 2024Article
- An Update on Pharmacologic Management of Neonatal Hypotension: When, Why, and Which Medication.Children (Basel, Switzerland) · 2024Review
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 19 institutions in 17 countries.
Funding
Abstract
backgroundIn the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks' postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment.
methodsOf the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks' postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children's Abilities-Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all. DISCUSSION: Follow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. To decrease the risk of generalisation and data-driven biased conclusions, we present a detailed description of the methodology for the SafeBoosC-III follow-up study. As funding is limited, a pragmatic approach is necessary.
trial registrationClinicalTrials.gov NCT05134116 . Registered on 24 November 2021.
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