Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cerebral oximetry monitoring device, Usual care.
- Who it may be relevant to
- Registry conditions: Hypoxia, Infant, Newborn, Diseases. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
Overview
The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that: i. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation. ii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.
Detailed description
SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).
Interventions
- Device Cerebral oximetry monitoring device
Participants in the experimental group will be monitored with cerebral oximetry, if possible before or, as soon as possible and within six hours after initiation of invasive mechanical ventilation. Cerebral oximetry will be continued until 1) the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, 2) extubation, 3) until 28 days after birth, or 4) until death. Randomisation will only direct the - Other Usual care
Treatment as usual
Primary outcome measures
- Hospital-free days within 90 days of randomisation [Time frame: 90 days]
- A composite of death from any cause or moderate to severe neurodevelopmental disability [Time frame: 2 years]
- Parental questionnaires [Time frame: 18-30 months]
Secondary outcome measures (2)
- Proportion of participants with a serious adverse event [Time frame: 90 days]
- Invasive mechanical ventilation-free days within 90 days of randomisation [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- Gestational age more than or equal to 28+0
- Postnatal age less than 28 days
- Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise
- Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method
- A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation
Exclusion criteria
- Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)
- Suspicion or diagnosis of congenital heart malformations likely to require surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Universitario 12 de Octubre — Madrid
Publications
- Vestager ML, Hansen ML, Rasmussen MI, Hahn GH, Hyttel-Sorensen S, Pellicer A, Heuchan AM, Hagmann C, Dempsey E, Dimitriou G, Pichler G, Naulaers G, Fuchs H, Tkaczyk J, Mintzer J, Fumagalli M, Nesargi S, Fredly S, Szczapa T, Gluud C, Jakobsen JC, Greisen G. The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial. Trials. 2023 PMID 37898759
- Kamp CB, Petersen JJ, Hansen ML, Pellicer A, Naulaers G, Dempsey E, Hahn GH, Olsen MH, Rasmussen MIS, Pichler G, Dimitriou G, Szczapa T, Ognean ML, Nesargi S, Musante G, Chalak L, Di Maio M, Lakhwani J, Procianoy RS, Tkaczyk J, Fuchs H, Cetinkaya M, Hagmann C, Popat H, Fabres J, Wang L, Schmolzer G, Fumagalli M, Piris-Borregas S, Mohora R, Zafra P, Sarafidis K, Alsina-Casanova M, Baik-Schneditz N, PMID 41845443
- Petersen JJ, Kamp CB, Olsen MH, Hansen ML, Thorlund K, Pellicer A, Naulaers G, Dempsey E, Hahn GH, Andersen PB, Rasmussen MIS, Pichler G, Dimitriou G, Szczapa T, Ognean ML, Nesargi S, Musante G, Chalak L, Di Maio M, Lakhwani J, Procianoy RS, Tkaczyk J, Fuchs H, Cetinkaya M, Hagmann C, Popat H, Fabres J, Wang L, Schmolzer G, Piris-Borregas S, Mohora R, Zafra P, Sarafidis K, Alsina-Casanova M, Baik- PMID 41413912
Identifiers
NCT: NCT05907317 · SafeBoosC-IIIv