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Safeguarding the Brain of Our Smallest Infants Phase III (SafeBoosC)

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ClinicalTrials.gov Identifier: NCT03770741
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Elsass Foundation
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant, Extremely Premature Brain Injuries Death, Brain Death; Neonatal Other: Modify cardio-respiratory support to avoid cerebral hypoxia Other: Treatment as usual Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
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
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : July 15, 2021

Arm Intervention/treatment
Experimental: Monitoring of cerebral oxygenation
Modify cardio-respiratory support to avoid cerebral hypoxia
Other: Modify cardio-respiratory support to avoid cerebral hypoxia
modification of cardio-respiratory support based on an evidence-based treatment guideline

Treatment as usual
Treatment according local guidelines and practices.
Other: Treatment as usual
Monitoring and treatment according to local guidelines and practice




Primary Outcome Measures :
  1. Severe brain injury or death [ Time Frame: From birth to 36 weeks postmenstrual age ]
    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


Other Outcome Measures:
  1. Major neonatal morbidities [ Time Frame: From birth to 36 weeks postmenstrual age ]
    A score 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

  2. Bronchopulmonary dysplasia [ Time Frame: From birth to 36 weeks postmenstrual age ]
    Oxygen or ventilator/continuous positive airway pressure (CPAP) requirement at the time of assessment

  3. Retinopathy of prematurity [ Time Frame: From birth to 36 weeks postmenstrual age ]
    Stage 3+ and above at any time until the time of assessment

  4. Necrotising enterocolitis [ Time Frame: From birth to 36 weeks postmenstrual age ]
    Stage 2 or higher using the modified Bell's staging system and/or focal intestinal perforation at any time until the time of assessment

  5. Sepsis [ Time Frame: From birth to 36 weeks postmenstrual age ]
    Late-onset sepsis (>72 hours after birth) defined as treatment with antibiotics for at least five days



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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants born with postmenstrual age less than 28 weeks
  • Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred consent as consent method.

Exclusion Criteria:

  • Missing written parental informed consent (if the 'opt-out' method is used for consent, lack of a record that the clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record in the infant's clinical file of parents' decision to opt-out, are exclusion criteria)
  • Decision not to conduct full life support
  • No possibility to place cerebral NIRS oximeter within six hours after birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770741


Contacts
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Contact: Gorm Greisen, MD, Prof 35451326 gorm.greisen@regionh.dk

Sponsors and Collaborators
Gorm Greisen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Elsass Foundation
Investigators
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Principal Investigator: Gorm Greisen, MD, Prof Rigshospitalet, Denmark

Additional Information:
Publications:
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Responsible Party: Gorm Greisen, Professor in Pediatrics, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03770741     History of Changes
Other Study ID Numbers: SafeBoosC-DP-363
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gorm Greisen, Rigshospitalet, Denmark:
Near-infrared spectroscopy
NIRS
Cerebral oximetry
Extremely preterm
Brain injury
Mortality
Treatment guideline

Additional relevant MeSH terms:
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Brain Injuries
Premature Birth
Death
Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations