<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770741</url>
  </required_header>
  <id_info>
    <org_study_id>SafeBoosC-DP-363</org_study_id>
    <nct_id>NCT03770741</nct_id>
  </id_info>
  <brief_title>Safeguarding the Brain of Our Smallest Infants Phase III</brief_title>
  <acronym>SafeBoosC</acronym>
  <official_title>Safeguarding the Brain of Our Smallest Children - an Investigator-initiated, Pragmatic, Open Label, Multinational Randomized Phase IIIclinical Trial Evaluating Treatment Based on Near-infrared Spectroscopy Monitoring Versus Treatment as Usual in Premature Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gorm Greisen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Copenhagen Trial Unit, Center for Clinical Intervention Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Elsass Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      the SafeBoosC-III trial investigates the benefit and harms of treatment based on&#xD;
      near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is&#xD;
      that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants&#xD;
      during the first 72 hours of life will result in a reduction in severe brain injury or death&#xD;
      at 36 weeks postmenstrual age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Each year, 50,000 extremely preterm infants are born in high-income countries with&#xD;
      access to neonatal intensive care. Of these, 10,000 will die and a further 10,000 will suffer&#xD;
      cerebral palsy or moderate-to-severe neuro-cognitive disability. Time spent outside normal&#xD;
      cerebral oxygenation ranges (time with hypoxia or hyperoxia) is associated with poor&#xD;
      neurological outcome in children and adults. Monitoring of cerebral oxygenation may reduce&#xD;
      the risk of cerebral complications, but no such effects have yet been demonstrated in preterm&#xD;
      infants in large randomised clinical trials. The recently completed SafeBoosC phase II trial&#xD;
      was conducted at eight sites in eight European countries. 166 extremely preterm infants were&#xD;
      randomised to visible monitoring of cerebral oxygenation by near-infrared spectroscopy (NIRS)&#xD;
      combined with an evidence-based treatment guideline (experimental group) versus blinded NIRS&#xD;
      and treatment as usual (control group). The trial found that NIRS monitoring in combination&#xD;
      with an evidence-based treatment guideline successfully reduced the burden of hypoxia and&#xD;
      hyperoxia from 81% to 36%hours during the first three days of life (p&lt;0.001). Furthermore,&#xD;
      the proportion of severe brain injury assessed by central reading of serial cranial&#xD;
      ultrasound was 12.5% in the experimental group versus 23.4% in the control group, RR 0.53&#xD;
      (95% CI: 0.26 to 1.08). Mortality was 14% in the experimental versus 25% in the control&#xD;
      group, RR 0.50 (95% CI: 0.29 to 1.00). No other evidence has been identified. Based on these&#xD;
      preliminary findings, we are planning a phase III randomised clinical trial; the&#xD;
      SafeBoosC-III trial.&#xD;
&#xD;
      Objectives The overall objective of the SafeBoosC-III trial is to investigate the benefit and&#xD;
      harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as&#xD;
      usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for&#xD;
      extremely preterm infants during the first 72 hours of life will result in a reduction in&#xD;
      severe brain injury or death at 36 weeks postmenstrual age.&#xD;
&#xD;
      Trial design The SafeBoosC-III trial will be an investigator-initiated, randomized,&#xD;
      multinational, pragmatic phase-III clinically open trial with a two-parallel group design.&#xD;
      Sixteen-hundred extremely preterm infants will be included within 24 months at 50 neonatal&#xD;
      intensive care units (NICUs) across 20 countries (less than two children per month per unit).&#xD;
      Data management and statistical analysis will be blinded.&#xD;
&#xD;
      Eligibility Eligible infants will be born before 28 weeks of postmenstrual age; decision is&#xD;
      made to provide full life support; signed informed consent (unless the NICU has chosen to use&#xD;
      'opt-out' or deferred consent as consent method); and cerebral NIRS oximeter placed within 6&#xD;
      hours after birth.&#xD;
&#xD;
      Interventions Participants in the experimental group will be monitored during the first 72&#xD;
      hours of life with a cerebral NIRS oximeter, placed within six hours after birth, and treated&#xD;
      according to an evidence-based treatment guideline. Participants in the control group will&#xD;
      not undergo cerebral oxygenation monitoring and will be treated as usual. Each participant&#xD;
      will be followed up at 36 weeks postmenstrual age.&#xD;
&#xD;
      Outcomes The primary outcome will be a composite of severe brain injury (cerebral haemorrhage&#xD;
      grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage,&#xD;
      post-haemorrhagic ventricular dilatation or cerebral atrophy) detected on any of the serial&#xD;
      cranial ultrasound scans that are routinely performed in these infants up to that age or&#xD;
      death until 36 weeks of postmenstrual age.&#xD;
&#xD;
      Exploratory outcomes will be a count of the presence of bronchopulmonary dysplasia,&#xD;
      retinopathy of prematurity stage 3+, and severe brain injury as defined in the primary&#xD;
      outcome, as well as bronchopulmonary dysplasia, retinopathy of prematurity stage +3,&#xD;
      necrotizing enterocolitis stage 2 or higher using the modified Bell's staging and/or focal&#xD;
      intestinal perforation, and late-onset sepsis (&gt;72 hours after birth) defined as treatment&#xD;
      with antibiotics for at least five days, as isolated outcomes.&#xD;
&#xD;
      Sample size We have calculated our sample size based on the primary outcome with an alpha of&#xD;
      5%, a power of 90%, and a ratio of 1:1 between intervention groups. In the SafeBoosC-II&#xD;
      trial, the proportion of trial participants in the control group with death or severe brain&#xD;
      injury was approximately 34%. Assuming the same proportion in the SafeBoosC phase III trial&#xD;
      control group and using 22% relative risk reduction as anticipated intervention effect, we&#xD;
      will need to randomise a total of 1,600 participants.&#xD;
&#xD;
      Safety Oximeters approved for clinical use in newborn infants will be used. Predefined&#xD;
      serious adverse events and serious adverse reactions will be reported separately. An&#xD;
      independent Data Monitoring and Safety Committee will be established to monitor the safety of&#xD;
      the trial participants during the trial.&#xD;
&#xD;
      Ethical considerations Approval from the relevant ethics committees and/or Institutional&#xD;
      Review Boards is mandatory for every participating centre. Written parental informed consent&#xD;
      will be obtained prior to randomisation unless the ethics committee has granted permission to&#xD;
      use deferred informed consent or prior informed assent. The trial will be conducted in&#xD;
      compliance with the guidelines of the Declaration of Helsinki in its latest form and of the&#xD;
      International Conference on Harmonisation Good Clinical Practice. Procedures will be&#xD;
      established to prevent and minimise risk of complications for participants, such as&#xD;
      complications related to the device handling. The evidence-based treatment guideline includes&#xD;
      only interventions that are commonly used during intensive care for this population.&#xD;
&#xD;
      Trial duration Recruitment will begin in April of 2019 and will be completed within 24 months&#xD;
      (April of 2021).&#xD;
&#xD;
      Perspectives If the experimental intervention proves successful, we may save at least 2,000&#xD;
      extremely preterm infants every year from death or a life with a handicap due to brain injury&#xD;
      in high-income countries. The ensuing health economics impact running into billions of Euros&#xD;
      saved annually.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2019</start_date>
  <completion_date type="Actual">December 16, 2021</completion_date>
  <primary_completion_date type="Actual">December 16, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Due to the nature of the experimental intervention, no blinding can be done for the clinical staff and the parents. Outcome assessment of mortality will not be blinded, but the diagnosis and classification of brain injury and the entry of this into the eCRF, will be done by a person that is blinded to group allocation. Principal investigators must develop a local procedure description that describe how this is done. The local procedure description must be approved by the sponsor. Furthermore, mortality will be checked by Good Clinical Practice (GCP) through source data verification in all patients. The data managers, statisticians and those drawing conclusions will be blinded to treatment allocation. Data management will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Severe brain injury or death</measure>
    <time_frame>From birth to 36 weeks postmenstrual age</time_frame>
    <description>A composite of severe brain injury detected on any one of a series of cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age or death at 36 weeks postmenstrual age</description>
  </primary_outcome>
  <other_outcome>
    <measure>Major neonatal morbidities</measure>
    <time_frame>From birth to 36 weeks postmenstrual age</time_frame>
    <description>A count of the presence of major neonatal morbidities associated with neurodevelopmental impairment later in life (48): bronchopulmonary dysplasia, retinopathy of prematurity as defined below, and severe brain injury as defined in the primary outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Bronchopulmonary dysplasia</measure>
    <time_frame>From birth to 36 weeks postmenstrual age</time_frame>
    <description>Oxygen or ventilator/continuous positive airway pressure (CPAP) requirement at the time of assessment</description>
  </other_outcome>
  <other_outcome>
    <measure>Retinopathy of prematurity</measure>
    <time_frame>From birth to 36 weeks postmenstrual age</time_frame>
    <description>Stage 3+ and above at any time until the time of assessment</description>
  </other_outcome>
  <other_outcome>
    <measure>Necrotising enterocolitis</measure>
    <time_frame>From birth to 36 weeks postmenstrual age</time_frame>
    <description>Stage 2 or higher using the modified Bell's staging system and/or focal intestinal perforation at any time until the time of assessment</description>
  </other_outcome>
  <other_outcome>
    <measure>Sepsis</measure>
    <time_frame>From birth to 36 weeks postmenstrual age</time_frame>
    <description>Late-onset sepsis (&gt;72 hours after birth) defined as treatment with antibiotics for at least five days</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1601</enrollment>
  <condition>Infant, Extremely Premature</condition>
  <condition>Brain Injuries</condition>
  <condition>Death, Brain</condition>
  <condition>Death; Neonatal</condition>
  <arm_group>
    <arm_group_label>Monitoring of cerebral oxygenation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modify cardio-respiratory support to avoid cerebral hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment according local guidelines and practices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modify cardio-respiratory support to avoid cerebral hypoxia</intervention_name>
    <description>modification of cardio-respiratory support based on an evidence-based treatment guideline</description>
    <arm_group_label>Monitoring of cerebral oxygenation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Monitoring and treatment according to local guidelines and practice</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born with postmenstrual age less than 28 weeks&#xD;
&#xD;
          -  Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred&#xD;
             consent as consent method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing written parental informed consent (if the 'opt-out' method is used for&#xD;
             consent, lack of a record that the clinical staff have explained the trial and the&#xD;
             'opt-out' consent process to parents and/or a record in the infant's clinical file of&#xD;
             parents' decision to opt-out, are exclusion criteria)&#xD;
&#xD;
          -  Decision not to conduct full life support&#xD;
&#xD;
          -  No possibility to place cerebral NIRS oximeter within six hours after birth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gorm Greisen, MD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.safeboosc.eu</url>
    <description>Trial website</description>
  </link>
  <reference>
    <citation>Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015 Jan 5;350:g7635. doi: 10.1136/bmj.g7635.</citation>
    <PMID>25569128</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 17, 2021</last_update_submitted>
  <last_update_submitted_qc>December 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Gorm Greisen</investigator_full_name>
    <investigator_title>Professor in Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Near-infrared spectroscopy</keyword>
  <keyword>NIRS</keyword>
  <keyword>Cerebral oximetry</keyword>
  <keyword>Extremely preterm</keyword>
  <keyword>Brain injury</keyword>
  <keyword>Mortality</keyword>
  <keyword>Treatment guideline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Death</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770741
org study id: SafeBoosC-DP-363
nct id: NCT03770741
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
the SafeBoosC-III trial investigates the benefit and harms of treatment based on
      near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is
      that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants
      during the first 72 hours of life will result in a reduction in severe brain injury or death
      at 36 weeks postmenstrual age.
Background Each year, 50,000 extremely preterm infants are born in high-income countries with
      access to neonatal intensive care. Of these, 10,000 will die and a further 10,000 will suffer
      cerebral palsy or moderate-to-severe neuro-cognitive disability. Time spent outside normal
      cerebral oxygenation ranges (time with hypoxia or hyperoxia) is associated with poor
      neurological outcome in children and adults. Monitoring of cerebral oxygenation may reduce
      the risk of cerebral complications, but no such effects have yet been demonstrated in preterm
      infants in large randomised clinical trials. The recently completed SafeBoosC phase II trial
      was conducted at eight sites in eight European countries. 166 extremely preterm infants were
      randomised to visible monitoring of cerebral oxygenation by near-infrared spectroscopy (NIRS)
      combined with an evidence-based treatment guideline (experimental group) versus blinded NIRS
      and treatment as usual (control group). The trial found that NIRS monitoring in combination
      with an evidence-based treatment guideline successfully reduced the burden of hypoxia and
      hyperoxia from 81% to 36%hours during the first three days of life (p<0.001). Furthermore,
      the proportion of severe brain injury assessed by central reading of serial cranial
      ultrasound was 12.5% in the experimental group versus 23.4% in the control group, RR 0.53
      (95% CI: 0.26 to 1.08). Mortality was 14% in the experimental versus 25% in the control
      group, RR 0.50 (95% CI: 0.29 to 1.00). No other evidence has been identified. Based on these
      preliminary findings, we are planning a phase III randomised clinical trial; the
      SafeBoosC-III trial.

      Objectives The overall objective of the SafeBoosC-III trial is to investigate the benefit and
      harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as
      usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for
      extremely preterm infants during the first 72 hours of life will result in a reduction in
      severe brain injury or death at 36 weeks postmenstrual age.

      Trial design The SafeBoosC-III trial will be an investigator-initiated, randomized,
      multinational, pragmatic phase-III clinically open trial with a two-parallel group design.
      Sixteen-hundred extremely preterm infants will be included within 24 months at 50 neonatal
      intensive care units (NICUs) across 20 countries (less than two children per month per unit).
      Data management and statistical analysis will be blinded.

      Eligibility Eligible infants will be born before 28 weeks of postmenstrual age; decision is
      made to provide full life support; signed informed consent (unless the NICU has chosen to use
      'opt-out' or deferred consent as consent method); and cerebral NIRS oximeter placed within 6
      hours after birth.

      Interventions Participants in the experimental group will be monitored during the first 72
      hours of life with a cerebral NIRS oximeter, placed within six hours after birth, and treated
      according to an evidence-based treatment guideline. Participants in the control group will
      not undergo cerebral oxygenation monitoring and will be treated as usual. Each participant
      will be followed up at 36 weeks postmenstrual age.

      Outcomes The primary outcome will be a composite of severe brain injury (cerebral haemorrhage
      grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage,
      post-haemorrhagic ventricular dilatation or cerebral atrophy) detected on any of the serial
      cranial ultrasound scans that are routinely performed in these infants up to that age or
      death until 36 weeks of postmenstrual age.

      Exploratory outcomes will be a count of the presence of bronchopulmonary dysplasia,
      retinopathy of prematurity stage 3+, and severe brain injury as defined in the primary
      outcome, as well as bronchopulmonary dysplasia, retinopathy of prematurity stage +3,
      necrotizing enterocolitis stage 2 or higher using the modified Bell's staging and/or focal
      intestinal perforation, and late-onset sepsis (>72 hours after birth) defined as treatment
      with antibiotics for at least five days, as isolated outcomes.

      Sample size We have calculated our sample size based on the primary outcome with an alpha of
      5%, a power of 90%, and a ratio of 1:1 between intervention groups. In the SafeBoosC-II
      trial, the proportion of trial participants in the control group with death or severe brain
      injury was approximately 34%. Assuming the same proportion in the SafeBoosC phase III trial
      control group and using 22% relative risk reduction as anticipated intervention effect, we
      will need to randomise a total of 1,600 participants.

      Safety Oximeters approved for clinical use in newborn infants will be used. Predefined
      serious adverse events and serious adverse reactions will be reported separately. An
      independent Data Monitoring and Safety Committee will be established to monitor the safety of
      the trial participants during the trial.

      Ethical considerations Approval from the relevant ethics committees and/or Institutional
      Review Boards is mandatory for every participating centre. Written parental informed consent
      will be obtained prior to randomisation unless the ethics committee has granted permission to
      use deferred informed consent or prior informed assent. The trial will be conducted in
      compliance with the guidelines of the Declaration of Helsinki in its latest form and of the
      International Conference on Harmonisation Good Clinical Practice. Procedures will be
      established to prevent and minimise risk of complications for participants, such as
      complications related to the device handling. The evidence-based treatment guideline includes
      only interventions that are commonly used during intensive care for this population.

      Trial duration Recruitment will begin in April of 2019 and will be completed within 24 months
      (April of 2021).

      Perspectives If the experimental intervention proves successful, we may save at least 2,000
      extremely preterm infants every year from death or a life with a handicap due to brain injury
      in high-income countries. The ensuing health economics impact running into billions of Euros
      saved annually.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Due to the nature of the experimental intervention, no blinding can be done for the clinical staff and the parents. Outcome assessment of mortality will not be blinded, but the diagnosis and classification of brain injury and the entry of this into the eCRF, will be done by a person that is blinded to group allocation. Principal investigators must develop a local procedure description that describe how this is done. The local procedure description must be approved by the sponsor. Furthermore, mortality will be checked by Good Clinical Practice (GCP) through source data verification in all patients. The data managers, statisticians and those drawing conclusions will be blinded to treatment allocation. Data management will be blinded.
measure: Severe brain injury or death
time frame: From birth to 36 weeks postmenstrual age
description: A composite of severe brain injury detected on any one of a series of cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age or death at 36 weeks postmenstrual age
measure: Major neonatal morbidities
time frame: From birth to 36 weeks postmenstrual age
description: A count of the presence of major neonatal morbidities associated with neurodevelopmental impairment later in life (48): bronchopulmonary dysplasia, retinopathy of prematurity as defined below, and severe brain injury as defined in the primary outcome
measure: Bronchopulmonary dysplasia
time frame: From birth to 36 weeks postmenstrual age
description: Oxygen or ventilator/continuous positive airway pressure (CPAP) requirement at the time of assessment
measure: Retinopathy of prematurity
time frame: From birth to 36 weeks postmenstrual age
description: Stage 3+ and above at any time until the time of assessment
measure: Necrotising enterocolitis
time frame: From birth to 36 weeks postmenstrual age
description: Stage 2 or higher using the modified Bell's staging system and/or focal intestinal perforation at any time until the time of assessment
measure: Sepsis
time frame: From birth to 36 weeks postmenstrual age
description: Late-onset sepsis (>72 hours after birth) defined as treatment with antibiotics for at least five days
arm group label: Monitoring of cerebral oxygenation
arm group type: Experimental
description: Modify cardio-respiratory support to avoid cerebral hypoxia
arm group label: Treatment as usual
arm group type: Other
description: Treatment according local guidelines and practices.
intervention type: Other
intervention name: Modify cardio-respiratory support to avoid cerebral hypoxia
description: modification of cardio-respiratory support based on an evidence-based treatment guideline
arm group label: Monitoring of cerebral oxygenation
intervention type: Other
intervention name: Treatment as usual
description: Monitoring and treatment according to local guidelines and practice
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Hours
healthy volunteers: No
last name: Gorm Greisen, MD, Prof
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
url: http://www.safeboosc.eu
description: Trial website
citation: Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015 Jan 5;350:g7635. doi: 10.1136/bmj.g7635.
PMID: 25569128
responsible party type: Sponsor-Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Gorm Greisen
investigator title: Professor in Pediatrics
mesh term: Brain Injuries
mesh term: Brain Death
mesh term: Premature Birth
mesh term: Death
sharing ipd: No