Actively Recruiting
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
Led by King's College Hospital NHS Trust · Updated on 2024-10-23
70
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
K
King's College Hospital NHS Trust
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth
You will not qualify if you...
- Preterm infants above 31 weeks completed gestation or term born infants
- Infants with major congenital abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
O
Ourania Kaltsogianni, MSc
CONTACT
T
Theodore Dassios, Consultant Neonatologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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