Back to resultsSafeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv) (SafeBoosC-IIIv)
Primary Purpose
Hypoxia, Infant, Newborn, Diseases
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cerebral oximetry monitoring device
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia focused on measuring Near-infrared spectroscopy, Randomised clinical trial, Mechanical ventilation
Eligibility Criteria
Inclusion Criteria: Gestational age more than 28+0 weeks Postnatal age less than 28 days Expected to receive mechanical ventilation for at least 24 hours, as judged by the physician intending to randomise Equipoise as regards the need for cerebral oximetry Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method. Exclusion Criteria: No signed parental informed consent (if prior consent is used), or lack of a record that the clinician has explained the trial to the parents and the parents agreed (if 'opt-out' is used,) Suspicion of or confirmed brain injury or disorder (e.g. perinatal asphyxia, cerebral haemorrhage, cerebral malformation, genetic or metabolic disease) A cerebral oximeter is not available Newborns with congenital heart malformations who is likely to need surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cerebral oximetry + usual care
Usual care
Arm Description
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
Outcomes
Primary Outcome Measures
A composite of death from any cause or moderate to severe neurodevelopmental disability
There will be two co-primary outcomes, a composite dichotomized outcome and a continuous outcome:
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
cerebral palsy with Global Motor Function Classification System level 2 or higher;
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);
hearing loss corrected with aids or worse; or
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.
Parental questionnaires
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).
Secondary Outcome Measures
Serious adverse events
One or more Serious Adverse Events after randomisation and within the 28 first days of life, i.e. one or more of the following
Death from any cause
Any brain injury diagnosed by imaging
Seizures treated with antiepileptic medicine
Necrotising enterocolitis (NEC) Bells grade 2 or more
Sepsis (confirmed or suspected infection treated with antibiotics for 5 days or more)
Extra Corporal Membrane Oxygenation (ECMO)
Renal replacement therapy
Use of vasopressor/inotropes
Nitric Oxygen treatment
On mechanical ventilation at 28 days of life
Days alive without mechanical ventilation
Full Information
NCT ID
NCT05907317
First Posted
June 8, 2023
Last Updated
June 16, 2023
Sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
1. Study Identification
Unique Protocol Identification Number
NCT05907317
Brief Title
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Acronym
SafeBoosC-IIIv
Official Title
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
February 1, 2029 (Anticipated)
Study Completion Date
February 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the SafeBoosC-IIIv trial is to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. The hypothesis is that 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Infant, Newborn, Diseases
Keywords
Near-infrared spectroscopy, Randomised clinical trial, Mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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. All secondary outcomes will be assessed and reported at 28 days after birth by reviewing the newborn's health care records. Investigators reviewing the health care records will, if possible, be blinded to the allocated intervention.
Data managers, statisticians, conclusion drawers, and the steering committee members will be blinded.
Allocation
Randomized
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerebral oximetry + usual care
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Cerebral oximetry monitoring device
Intervention Description
The experimental group will receive cerebral oximetry added to usual care, if possible before or, as soon as possible and within six hours after mechanical ventilation has been initiated, and continuing until the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, until 28 days after birth, or until death.
The devices used are approved for clinical use in newborns and will be used according to the user manuals provided by the manufacturers. Furthermore, all clinical staff will be offered web-based training and certification that covers the principles of cerebral oximetry, practical application, as well as pathophysiology, and relevant interventions in the case of low cerebral oxygenation.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care offered to newborns in the control group will be offered equally in the experimental group (e.g. antibiotics; nutrition; etc.). There will be no attempt to standardize 'usual care' among centres.
Primary Outcome Measure Information:
Title
A composite of death from any cause or moderate to severe neurodevelopmental disability
Description
There will be two co-primary outcomes, a composite dichotomized outcome and a continuous outcome:
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
cerebral palsy with Global Motor Function Classification System level 2 or higher;
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);
hearing loss corrected with aids or worse; or
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.
Time Frame
2 years
Title
Parental questionnaires
Description
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).
Time Frame
18-30 months
Secondary Outcome Measure Information:
Title
Serious adverse events
Description
One or more Serious Adverse Events after randomisation and within the 28 first days of life, i.e. one or more of the following
Death from any cause
Any brain injury diagnosed by imaging
Seizures treated with antiepileptic medicine
Necrotising enterocolitis (NEC) Bells grade 2 or more
Sepsis (confirmed or suspected infection treated with antibiotics for 5 days or more)
Extra Corporal Membrane Oxygenation (ECMO)
Renal replacement therapy
Use of vasopressor/inotropes
Nitric Oxygen treatment
On mechanical ventilation at 28 days of life
Time Frame
28 days
Title
Days alive without mechanical ventilation
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Individual Serious Adverse Events
Description
as listed in the secondary outcome
Time Frame
28 days
Title
Days alive outside hospital within the 28 first days of life
Time Frame
28 days
Title
Cerebral palsy
Description
defined as Global Motor Function Classification System level 2 or above, at two years of corrected age.
Time Frame
2 years
Title
Sensory deficit
Description
defined as any degree of vision or hearing impairment, at two years of corrected age.
Time Frame
2 years
Title
Mortality
Description
Mortality at two years of corrected age.
Time Frame
2 years
Title
Use of medication
Description
Use of medication during the last two months, at two years of corrected age.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age more than 28+0 weeks
Postnatal age less than 28 days
Expected to receive mechanical ventilation for at least 24 hours, as judged by the physician intending to randomise
Equipoise as regards the need for cerebral oximetry
Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method.
Exclusion Criteria:
No signed parental informed consent (if prior consent is used), or lack of a record that the clinician has explained the trial to the parents and the parents agreed (if 'opt-out' is used,)
Suspicion of or confirmed brain injury or disorder (e.g. perinatal asphyxia, cerebral haemorrhage, cerebral malformation, genetic or metabolic disease)
A cerebral oximeter is not available
Newborns with congenital heart malformations who is likely to need surgery.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
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