Status:
COMPLETED
Safeguarding the Brain of Our Smallest Infants Phase III
Lead Sponsor:
Gorm Greisen
Collaborating Sponsors:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Elsass Foundation
Conditions:
Infant, Extremely Premature
Brain Injuries
Eligibility:
All Genders
Up to 6 years
Phase:
NA
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-...
Detailed Description
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 pal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
1601 Patients enrolled
Trial Details
Trial ID
NCT03770741
Start Date
June 20 2019
End Date
December 16 2021
Last Update
December 20 2021
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100