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Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants

Study acronym: FiO2-C
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Phase: Not applicable to Phase 3v6 Show 5 more changesShow less
    • Primary completion date: Dec 2023 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 2340 to confirmed 1065
    • Study completion date: Dec 2025 to Dec 2026
    • Site details revised at 32 of 32 sites
  2. Primary completion date: Oct 2022 to Dec 2023v5 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 10 to 32
    • Study completion date: Dec 2022 to Dec 2025
    • Secondary endpoints: 17 to 16
    • Study description expanded, about 286 words
  3. Study sites: 2 to 10
    • Publications: details revised at 1 of 3 entries
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 2018 to Jul 27, 2018
    v3
  5. Start date: Jul 2017 to Jun 2018v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT03168516
Lead Sponsor University Hospital Tuebingen
Conditions
(from sponsor)		 Infant,Premature
Related terms Premature Birth
Enrollment 1,065 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov