Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants
NCT ID: NCT03168516
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1065 participants
INTERVENTIONAL
2018-07-27
2026-12-31
Brief Summary
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Detailed Description
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The vast majority of ELGANs require supplemental oxygen in addition to mechanical respiratory support (including CPAP). Irrespective of the SpO2 target, the vast majority of ELGANs suffers from recurrent intermittent hypoxemic and (as a consequence of inappropriate adjustments of FiO2) hyperoxemic episodes. Recurrent intermittent hypoxic episodes - i.e. wide fluctuations in oxygen levels - are associated with an increased risk of ROP and there are data that suggest that late deaths and neurodevelopmental impairment are also linked to them.
Continuous positive airway pressure (CPAP) has been shown to reduce extubation failure in preterm infants, which may in part be due to a reduced frequency and severity of apnea of prematurity and stabilized functional residual capacity during apnea. Keeping oxygen levels (i.e., SpO2) stable despite irregular breathing patterns in ELGANs, requires frequent adjustments of the FiO2 which is both challenging, time consuming, and often impossible due to limited personnel resources.
FiO2-Controllers have been developed by several manufacturers of infant ventilators. They reduce the burden of hyper-/hypoxemia in infants while being safe and accurate in very short-term studies. The effects of FiO2-C on clinically relevant outcome measures and the safety of long-term continuous application, however, have yet to be elucidated. Hence there is now a window of opportunity to assess this new technology for benefits and harms, before it is implemented into neonatal care without appropriate evaluation of its safety and efficacy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental intervention
closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
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
Control intervention
Standard care, i.e. manual adjustments of the FiO2 only
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congenital anomalies
* postnatal age \> 48h
* missing parental consent
* lack of device enabling closed-loop automatic control of FiO2
48 Hours
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Axel Franz, Prof. Dr.
Role: STUDY_DIRECTOR
University Children's Hospital Tuebingen
Locations
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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
Countries
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References
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Maiwald CA, Niemarkt HJ, Poets CF, Urschitz MS, Konig J, Hummler H, Bassler D, Engel C, Franz AR; FiO2-C Study Group. Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy. BMC Pediatr. 2019 Oct 21;19(1):363. doi: 10.1186/s12887-019-1735-9.
Konig J, Stauch A, Engel C, Urschitz MS, Franz AR; FiO2-C study group. Statistical analysis plan for the FiO2-C trial: effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcomes of extremely preterm infants-a randomized-controlled parallel group multicentre trial for safety and efficacy. Trials. 2024 Nov 12;25(1):756. doi: 10.1186/s13063-024-08615-7.
Related Links
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study homepage
Other Identifiers
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2018-000453-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BMBF-Fz01KG1602
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FiO2-C
Identifier Type: -
Identifier Source: org_study_id