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Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants
Sponsor: University Hospital Tuebingen
Summary
Extremely low gestational age neonates (ELGANs), i.e. those born at \<28 weeks, 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 development and death. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2-C) 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 FiO2-C in addition to manual adjustments, in comparison with manual adjustments of FiO2 only, on death and severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in ELGANs. The results of this trial may help to improve the quality of life of ELGANs and reduce the burden of significant morbidity as well as costs for health care and society
Official 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
Key Details
Gender
All
Age Range
Any - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
1065
Start Date
2018-07-27
Completion Date
2026-12
Last Updated
2023-12-27
Healthy Volunteers
No
Conditions
Interventions
closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
Application of FiO2-C (provided by standard infant ventilators) in addition to manual adjustments of the inspired oxygen fraction (FiO2) during mechanical ventilation and continuous positive airway pressure (CPAP) in ELGANs at least up to 32weeks PMA according to a standardized protocol
Locations (32)
Northwest Women's and Children's Hospital
Xi'an, China
Klinikum St. Marien - Klinik für Kinder und Jugendliche
Amberg, Germany
Josefinum - Klinik für Kinder und Jugendliche
Augsburg, Germany
Diakonie Krankenhaus der Kreuznacher Diakonie
Bad Kreuznach, Germany
Klinikum Links der Weser
Bremen, Germany
Universitätsklinikum Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
HELIOS Klinikum Erfurt
Erfurt, Germany
Klinikum Esslingen GmbH - Klinik für Kinder und Jugendliche
Esslingen am Neckar, Germany
Zentrum für Kinder- und Jugendmedizin
Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
University Hospital Leipzig
Leipzig, Germany
Städtisches Klinikum - Klinik für Neonatologie
München, Germany
München Klinik Harlaching
München, Germany
Universitätsklinikum München
München - Großhadern, Germany
Klinik für Kinder- und Jugendmedizin
Münster, Germany
Klinik Hallerwiese - Cnopf'sche Kinderklinik
Nuremberg, Germany
Krankenhaus Barmherzige Brüder
Regensburg, Germany
Klinikum am Steinenberg
Reutlingen, Germany
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
Schweinfurt, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, Germany
Klinikum Stuttgart, Olgahospital
Stuttgart, Germany
University Hospital Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Schwarzwald-Baar-Klinik
Villingen-Schwenningen, Germany
Rems-Murr-Kliniken gGmbH
Winnenden, Germany
Kindergeneeskunde Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
Máxima Medical Center
Veldhoven, Netherlands
Isala Kliniek Zwolle - Location Sophia
Zwolle, Netherlands
The James Cook University Hospital
Middlesbrough, United Kingdom