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. 2023 Oct 7;24(1):653.
doi: 10.1186/s13063-023-07653-x.

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

Marie Isabel Rasmussen  1 , Mathias Lühr Hansen  2   3 , Adelina Pellicer  4 , Christian Gluud  3   5 , Eugene Dempsey  6 , Jonathan Mintzer  7 , Simon Hyttel-Sørensen  8 , Anne Marie Heuchan  9 , Cornelia Hagmann  10 , Ebru Ergenekon  11 , Gabriel Dimitriou  12 , Gerhard Pichler  13 , Gunnar Naulaers  14 , Guoqiang Cheng  15 , Jakub Tkaczyk  16 , Hans Fuchs  17 , Monica Fumagalli  18   19 , Saudamini Nesargi  20 , Siv Fredly  21 , Tomasz Szczapa  22 , Anne Mette Plomgaard  23 , Bo Mølholm Hansen  24 , Janus Christian Jakobsen  3   5 , Gorm Greisen  2
Affiliations

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

Marie Isabel Rasmussen et al. Trials. .

Abstract

Background: In 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.

Methods: Of 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 registration: ClinicalTrials.gov NCT05134116 . Registered on 24 November 2021.

Keywords: Brain injury; Follow-up; Near-infrared spectroscopy; Neurodevelopment; Preterm; Protocol; Randomised clinical trial.

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Conflict of interest statement

The authors declare that they have no competing interests.

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Fig. 1
SPIRIT schedule of enrollment and assessment
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