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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral oximetry + usual care | Experimental |
| |
| Usual care | Other | The control group will receive mechanical ventilation without access to cerebral oximetry and the SafeBoosC treatment guideline. If the newborn is cared for outside the neonatal unit at any time, e.g. during surgery, cerebral oximetry may or may not be used, as decided by the responsible physician there |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral oximetry monitoring device | 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 use of cerebral oximetry during the first invasive mechanical ventilation episode. Cerebral oximetry will be used to minimise cerebral hypoxia by modifying clinical care according to the SafeBoosC treatment guideline and monitoring as usual. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-free days within 90 days of randomisation | Primary outcome for step one | 90 days |
| A composite of death from any cause or moderate to severe neurodevelopmental disability | Co-primary outcome for step two A composite of death from any cause or moderate to severe neurodevelopmental disability at two years of corrected age. Moderate to severe neurodevelopmental disability will be defined as one or more of the following
| 2 years |
| Parental questionnaires | Co-primary outcome for step two: Parental questionnaires completed between 18-30 months' corrected age as well as available data from at least 12 months' corrected age from health care records, including standardised neurodevelopmental assessments, will be used to assess mortality and neurodevelopment. • Non-verbal cognitive score of Parent Report of Children's Abilities-Revised (PARCA-R), a parental questionnaire, at two years of corrected age (range 0-34, higher score means better outcome). | 18-30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a serious adverse event | Secondary outcome for step one: Proportion of participants with one or more Serious Adverse Events within the 90 days of randomization, i.e. one or more of the following: Death from any cause Bronchopulmonary dysplasia (BPD) Any brain injury diagnosed by imaging Seizures treated with antiepileptic medicine Haemodynamic insufficiency that needs cardiovascular support Spontaneous bowel perforation or necrotising enterocolitis (NEC) Bells grade 2 or more Nosocomial infection Extra Corporal Membrane Oxygenation (ECMO) Renal replacement therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Late onset sepsis | Exploratory outcome for step one | 90 days |
| Invasive mechanical ventilation-related infection | Exploratory outcome for step one |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Kamp, PhD | Contact | +45 20 32 41 08 | caroline.kamp@ctu.dk | |
| Johanne Juul Petersen | Contact | +45 28 93 30 35 | johanne.juul.petersen@ctu.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37898759 | Background | 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 Oct 28;24(1):696. doi: 10.1186/s13063-023-07699-x. | |
| 41845443 |
| Label | URL |
|---|---|
| Official website of the trial | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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The trial will recruit 1610 babies in step one. Randomisation will continue until 3000 babies are recruited in step two.
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Step one: The primary outcome will be assessed by a blinded investigator. The principal investigator from each centre must develop a local blinding procedure, describing how blinding is achieved. To support the principal investigators in this work, a Standard Operation Procedure with suggestions for blinding procedures will be developed. Data managers, statisticians, and conclusion drawers will be blinded.
Step two: Due to the nature of the experimental intervention, clinical staff and the parents will not be blinded to group allocation. Thus, the primary outcome will not be blinded in cases when it relies on parental reporting. If there is no contact with the parents, or if they do not return the questionnaire, data will be collected from health care records. Investigators reviewing the health care records will, if possible, be blinded to the allocated intervention. Data managers, statisticians, and conclusion drawers will be blinded.
|
| Usual care | Other | Treatment as usual |
|
| 90 days |
| Invasive mechanical ventilation-free days within 90 days of randomisation | Secondary outcome for step one | 90 days |
| 90 days |
| Cerebral palsy | Exploratory outcome for step two: defined as Global Motor Function Classification System level 2 or above, at two years of corrected age. | 2 years |
| Sensory deficit | exploratory outcome for step two: defined as any degree of vision or hearing impairment, at two years of corrected age. | 2 years |
| All-cause mortality | Exploratory outcome for step two: Mortality at two years of corrected age. | 2 years |
| Use of daily medication | Exploratory outcome for step two: Use of medication during the last two months, at two years of corrected age. | 2 years |
| Derived |
| 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, Lopez LS, Griesmaier E, Hatzidaki E, A S, Dassios T, Greisen G, Jakobsen JC. Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial. Trials. 2026 Mar 17;27(1):318. doi: 10.1186/s13063-026-09631-5. |
| 41413912 | Derived | 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-Schneditz N, Lopez LS, Griesmaier E, Hatzidaki E, Shashidhar A, Dassios T, Arruza L, Greisen G, Jakobsen JC. Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial. Trials. 2025 Dec 18;27(1):72. doi: 10.1186/s13063-025-09387-4. |