Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

NCT05907317 | Recruiting Phase 3 DMC

• 1 other identifier: SafeBoosC-IIIv
• Study Type: interventional
• Target: 1,610
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia; Infant, Newborn, Diseases

Keywords

Near-infrared spectroscopy; Randomised clinical trial; Mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• 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 1. cerebral palsy with Global Motor Function Classification System level 2 or higher; 2. a Parent Report of Children's Abilities-Revised (PARCA-R) non-verbal cognitive function score (range 0-34, higher score means better outcome) below -2 standard deviations (SD); 3. hearing loss corrected with aids or worse; or 4. vision impairment defined as moderately reduced vision of one eye, or only being able to perceive light or light reflecting objects; or blind in one eye with good vision in the contralateral eye.

  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

Secondary Outcomes (2)

• Proportion of participants with a serious adverse event

  90 days

• Invasive mechanical ventilation-free days within 90 days of randomisation

  90 days

Other Outcomes (6)

• Late onset sepsis

  90 days

• Invasive mechanical ventilation-related infection

  90 days

• Cerebral palsy

  2 years

Study Arms (2)

Cerebral oximetry + usual care

EXPERIMENTAL

Device: Cerebral oximetry monitoring device; Other: Usual care

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

Other: Usual care

Interventions

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.

Cerebral oximetry + usual care

Usual care OTHER

Treatment as usual

Cerebral oximetry + usual care; Usual care

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 37898759 BACKGROUND

• 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. doi: 10.1186/s13063-025-09387-4. Online ahead of print.

  PMID: 41413912 DERIVED

Related Links

• Official website of the trial

MeSH Terms

Conditions

Hypoxia; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will recruit 1610 babies in step one. Randomisation will continue until 3000 babies are recruited in step two.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: April 11, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 25, 2025

Record last verified: 2025-01

Locations

ES (1)