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

Studies

Study First Submitted Date 2023-06-08
Study First Posted Date 2023-06-18
Last Update Posted Date 2023-06-18
Start Month Year February 1, 2024
Primary Completion Month Year February 1, 2029
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-18

Conditions

Sequence: 52486543 Sequence: 52486544
Name Hypoxia Name Infant, Newborn, Diseases
Downcase Name hypoxia Downcase Name infant, newborn, diseases

Id Information

Sequence: 40384163
Id Source org_study_id
Id Value SafeBoosC-IIIv

Design Groups

Sequence: 55942805 Sequence: 55942806
Group Type Experimental Group Type Other
Title Cerebral oximetry + usual care Title Usual care
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

Interventions

Sequence: 52795692 Sequence: 52795693
Intervention Type Device Intervention Type Other
Name Cerebral oximetry monitoring device Name Usual care
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. 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.

Keywords

Sequence: 80296469 Sequence: 80296470 Sequence: 80296471
Name Near-infrared spectroscopy Name Randomised clinical trial Name Mechanical ventilation
Downcase Name near-infrared spectroscopy Downcase Name randomised clinical trial Downcase Name mechanical ventilation

Design Outcomes

Sequence: 178560711 Sequence: 178560712 Sequence: 178560713 Sequence: 178560714 Sequence: 178560715 Sequence: 178560716 Sequence: 178560717 Sequence: 178560718 Sequence: 178560719 Sequence: 178560720
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure A composite of death from any cause or moderate to severe neurodevelopmental disability Measure Parental questionnaires Measure Serious adverse events Measure Days alive without mechanical ventilation Measure Individual Serious Adverse Events Measure Days alive outside hospital within the 28 first days of life Measure Cerebral palsy Measure Sensory deficit Measure Mortality Measure Use of medication
Time Frame 2 years Time Frame 18-30 months Time Frame 28 days Time Frame 28 days Time Frame 28 days Time Frame 28 days Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years
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. 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). 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 Description as listed in the secondary outcome Description defined as Global Motor Function Classification System level 2 or above, at two years of corrected age. Description defined as any degree of vision or hearing impairment, at two years of corrected age. Description Mortality at two years of corrected age. Description Use of medication during the last two months, at two years of corrected age.

Browse Conditions

Sequence: 194690650 Sequence: 194690651 Sequence: 194690652
Mesh Term Infant, Newborn, Diseases Mesh Term Hypoxia Mesh Term Signs and Symptoms, Respiratory
Downcase Mesh Term infant, newborn, diseases Downcase Mesh Term hypoxia Downcase Mesh Term signs and symptoms, respiratory
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48612208
Agency Class OTHER
Lead Or Collaborator lead
Name Copenhagen Trial Unit, Center for Clinical Intervention Research

Design Group Interventions

Sequence: 68580115 Sequence: 68580116 Sequence: 68580117
Design Group Id 55942805 Design Group Id 55942805 Design Group Id 55942806
Intervention Id 52795692 Intervention Id 52795693 Intervention Id 52795693

Eligibilities

Sequence: 30946025
Gender All
Minimum Age 0 Days
Maximum Age 28 Days
Healthy Volunteers No
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.
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254312602
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 0
Maximum Age Num 28
Minimum Age Unit Days
Maximum Age Unit Days
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 6

Designs

Sequence: 30691623
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
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.
Investigator Masked True

Responsible Parties

Sequence: 29058372
Responsible Party Type Sponsor