Project FiO2-C – Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of…

Basic data

Acronym:
FiO2-C
Title:
Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants- a randomized controlled parallel group multicenter trial for safety and efficacy
Duration:
01/04/2016 to 30/09/2022
Abstract / short description:
Preterm infants of extremely low gestational age at birth, i.e. <28 weeks, (ELGANs) frequently experience intermittent hypoxemic/hyperoxemic episodes. Observational data indicate that severe and prolonged hypoxemic episodes are associated with retinopathy of prematurity (ROP), impaired long-term develop-ment and death. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2C) reduces time outside the oxygen target range, decreases number and duration of hypo- and hyperoxemic episodes, and reduces caregivers’ workload. The proposed observer-blinded randomized controlled trial was designed and will be powered to compare the effect of FiO2C in addition to manual adjustments in com-parison with manual adjustments of FiO2 only on death, severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in ELGANs. The primary outcome measure will be a composite of death, severe ROP, chronic lung disease, or necrotizing enterocolitis until discharge. The co-primary outcome variable will be death or major neurodevelopmental impairment deter-mined at 24 months corrected age. Key secondary outcome variables are the individual components of the primary outcomes, the developmental scores of the Bayley Scales (III ed.) and brain injury scores on cerebral MRI at term. Safety analyses will assess adverse events and complications of prematurity. The results of this trial may help to improve the quality of life of ELGANs and reduce health care costs.
Keywords:
neonatology
Neonatologie
Investigator Initiated Trial
Center for Pediatric Clinical Studies

Staff

Managers

University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine

Contact persons

Faculty of Medicine
University of Tübingen

Local organizational units

Paediatrics Department IV
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine

Funders

Bonn, Nordrhein-Westfalen, Germany
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