TY - JOUR
T1 - Treatment guided by cerebral oximetry in mechanically ventilated newborns
T2 - a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial
AU - Petersen, Johanne Juul
AU - Kamp, Caroline Barkholt
AU - Olsen, Markus Harboe
AU - Hansen, Mathias Lühr
AU - Thorlund, Kristian
AU - Pellicer, Adelina
AU - Naulaers, Gunnar
AU - Dempsey, Eugene
AU - Hahn, Gitte Holst
AU - Andersen, Patrick Bjerregaard
AU - Rasmussen, Marie Isabel Skov
AU - Pichler, Gerhard
AU - Dimitriou, Gabriel
AU - Szczapa, Tomasz
AU - Ognean, Maria Livia
AU - Nesargi, Saudamini
AU - Musante, Gabriel
AU - Chalak, Lina
AU - Di Maio, Massimo
AU - Lakhwani, Jyoti
AU - Procianoy, Renato S
AU - Tkaczyk, Jakub
AU - Fuchs, Hans
AU - Cetinkaya, Merih
AU - Hagmann, Cornelia
AU - Popat, Himanshu
AU - Fabres, Jorge
AU - Wang, Laishuan
AU - Schmölzer, Georg
AU - Piris-Borregas, Salvador
AU - Mohora, Ramona
AU - Zafra, Pamela
AU - Sarafidis, Kosmas
AU - Alsina-Casanova, Miguel
AU - Baik-Schneditz, Nariae
AU - Lopez, Laura Serrano
AU - Griesmaier, Elke
AU - Hatzidaki, Eleftheria
AU - Shashidhar, A
AU - Dassios, Theodore
AU - Arruza, Luis
AU - Greisen, Gorm
AU - Jakobsen, Janus Christian
N1 - © 2025. The Author(s).
PY - 2025/12/18
Y1 - 2025/12/18
N2 - BACKGROUND: Newborns requiring invasive mechanical ventilation are at high risk of neurodevelopmental impairment, prolonged hospitalisation, and increased mortality. Treatment guided by cerebral oximetry monitoring has been proposed to reduce morbidity and mortality.METHODS: The SafeBoosC-IIIv trial is a multicentre, parallel-group, randomised clinical trial. The trial will be conducted in two steps. This is a statistical analysis plan for step one. The objective of step one is to assess whether treatment guided by cerebral oximetry monitoring, compared with usual care, increases the number of hospital-free days in newborns receiving invasive mechanical ventilation. Inclusion criteria are gestational age ≥ 28 + 0 weeks, postnatal age less than 28 days, expected to receive invasive mechanical ventilation (intubation) for at least 24 h, and a cerebral oximeter available so monitoring can be started within 6 h after initiation of invasive mechanical ventilation. Exclusion criteria are suspicion of or confirmed brain injury or congenital heart malformation likely to require surgery. A total of 1610 participants will be randomised 1:1 to treatment guided by cerebral oximetry monitoring or usual care. The primary outcome will be hospital-free days within 90 days of randomisation, which will be analysed with the van Elteren test stratified by 'centre'. This statistical analysis plan provides a detailed description of the planned analyses, including methods for handling missing data and assessing statistical assumptions. Analyses will follow the intention-to-treat principle and will be performed independently by two statisticians.CONCLUSION: This statistical analysis plan describes the planned statistical analyses in detail for step one of the SafeBoosC-IIIv trial.TRIAL REGISTRATION: ClinicalTrials.gov NCT05907317. First submitted on 8 June 2023, https://clinicaltrials.gov/study/NCT05907317 .
AB - BACKGROUND: Newborns requiring invasive mechanical ventilation are at high risk of neurodevelopmental impairment, prolonged hospitalisation, and increased mortality. Treatment guided by cerebral oximetry monitoring has been proposed to reduce morbidity and mortality.METHODS: The SafeBoosC-IIIv trial is a multicentre, parallel-group, randomised clinical trial. The trial will be conducted in two steps. This is a statistical analysis plan for step one. The objective of step one is to assess whether treatment guided by cerebral oximetry monitoring, compared with usual care, increases the number of hospital-free days in newborns receiving invasive mechanical ventilation. Inclusion criteria are gestational age ≥ 28 + 0 weeks, postnatal age less than 28 days, expected to receive invasive mechanical ventilation (intubation) for at least 24 h, and a cerebral oximeter available so monitoring can be started within 6 h after initiation of invasive mechanical ventilation. Exclusion criteria are suspicion of or confirmed brain injury or congenital heart malformation likely to require surgery. A total of 1610 participants will be randomised 1:1 to treatment guided by cerebral oximetry monitoring or usual care. The primary outcome will be hospital-free days within 90 days of randomisation, which will be analysed with the van Elteren test stratified by 'centre'. This statistical analysis plan provides a detailed description of the planned analyses, including methods for handling missing data and assessing statistical assumptions. Analyses will follow the intention-to-treat principle and will be performed independently by two statisticians.CONCLUSION: This statistical analysis plan describes the planned statistical analyses in detail for step one of the SafeBoosC-IIIv trial.TRIAL REGISTRATION: ClinicalTrials.gov NCT05907317. First submitted on 8 June 2023, https://clinicaltrials.gov/study/NCT05907317 .
KW - Humans
KW - Oximetry/statistics & numerical data
KW - Infant, Newborn
KW - Respiration, Artificial/adverse effects
KW - Multicenter Studies as Topic
KW - Randomized Controlled Trials as Topic
KW - Treatment Outcome
KW - Cerebrovascular Circulation
KW - Time Factors
KW - Data Interpretation, Statistical
KW - Predictive Value of Tests
KW - Gestational Age
U2 - 10.1186/s13063-025-09387-4
DO - 10.1186/s13063-025-09387-4
M3 - Article
C2 - 41413912
SN - 1468-6708
VL - 27
SP - 72
JO - Trials
JF - Trials
IS - 1
ER -