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Optimising Ventilation in Preterms With Closed-loop Oxygen Control

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated October 23, 2024 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary and study completion dates: Aug 2024 to Mar 2025v6
  2. Notable Primary and study completion dates: Aug 2023 to Aug 2024v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Minor Start date changed from estimate of Sep 2021 to Sep 5, 2021v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2021 to Sep 2021
    • Site details revised
    • Study description expanded, about 2 words
    v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored. Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner. With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.
Trial Details
NCT Number NCT05030337
Lead Sponsor King's College Hospital NHS Trust
Collaborators: King's College London
Conditions
(from sponsor)
Infant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation Complication
Related terms Infant, Premature, Diseases
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov