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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Care | Study protocol

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

Authors: Marie Isabel Rasmussen, Mathias Lühr Hansen, Adelina Pellicer, Christian Gluud, Eugene Dempsey, Jonathan Mintzer, Simon Hyttel-Sørensen, Anne Marie Heuchan, Cornelia Hagmann, Ebru Ergenekon, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Guoqiang Cheng, Jakub Tkaczyk, Hans Fuchs, Monica Fumagalli, Saudamini Nesargi, Siv Fredly, Tomasz Szczapa, Anne Mette Plomgaard, Bo Mølholm Hansen, Janus Christian Jakobsen, Gorm Greisen

Published in: Trials | Issue 1/2023

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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.
Appendix
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Metadata
Title
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
Authors
Marie Isabel Rasmussen
Mathias Lühr Hansen
Adelina Pellicer
Christian Gluud
Eugene Dempsey
Jonathan Mintzer
Simon Hyttel-Sørensen
Anne Marie Heuchan
Cornelia Hagmann
Ebru Ergenekon
Gabriel Dimitriou
Gerhard Pichler
Gunnar Naulaers
Guoqiang Cheng
Jakub Tkaczyk
Hans Fuchs
Monica Fumagalli
Saudamini Nesargi
Siv Fredly
Tomasz Szczapa
Anne Mette Plomgaard
Bo Mølholm Hansen
Janus Christian Jakobsen
Gorm Greisen
Publication date
01-12-2023
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07653-x

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