Condition: Hypoxia · Infant, Newborn, Diseases · Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that: i. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation. ii. 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.
This description comes directly from the study's public registry record.
Caroline Kamp, PhD · +45 20 32 41 08 · caroline.kamp@ctu.dk
Johanne Juul Petersen · +45 28 93 30 35 · johanne.juul.petersen@ctu.dk
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| Hospital Universitario 12 de Octubre | Madrid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05907317