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NCT05657795
Optimising Neonatal Ventilation With Closed-loop Oxygen Control
Conditions: Infant, Newborn, Diseases, Mechanical Ventilation Complication
Sex: All
Phase: NA
Enrollment: 40
Sponsor: King's College Hospital NHS Trust
Location: United Kingdom
Summary
Ventilated newborns frequently need supplemental oxygen but its use must be monitored carefully as both giving too much or too little oxygen can have harmful effects.
Giving too little oxygen results to low oxygen levels (hypoxia) and increases the risk of complications and mortality.
Excessive oxygen delivery (hyperoxia) increases the risk of diseases involving several organs such as the retinas and the lungs.
Although infants born very preterm require support with their breathing more often, more mature neonates may also need to be ventilated at birth and to receive supplemental oxygen.
Therefore, they may suffer from problems related to hypoxia and hyperoxia.For the above reasons, oxygen levels are continuously monitored and the amount of oxygen provided is manually adjusted by the nurses and doctors.Closed-loop automated oxygen control systems (CLAC) are a more recent approach that involves the use of a computer software added to the ventilator.
This software allows for automatic adjustment of the amount of oxygen provided to the baby in order to maintain oxygen levels within a desired target range depending on the baby's age and clinical condition.
Previous studies in preterm and very small infants showed that automated oxygen control systems provided the right amount of oxygen for most of the time and prevented hypoxia and hyperoxia with fewer manual adjustments required by clinical staff.
Preliminary results from a study that included infants born at 34 weeks gestation and beyond showed that CLAC systems allowed to reduce the amount of supplementary oxygen more rapidly.
With this study we aim to compare the time spent in hyperoxia and the overall duration of oxygen treatment between infants whose oxygen is adjusted either manually or automatically while they remain ventilated.
This will help us understand if CLAC systems help reduce the complications related to oxygen treatment.
Eligibility Criteria
Inclusion Criteria:Infants born at or above 34 weeks completed gestation requiring mechanical ventilation and admitted to King's NICU within 24 hours of initiation of mechanical ventilation.Exclusion Criteria:Preterm infants less than 34 weeks gestationInfants with cyanotic congenital heart diseaseInfants on high frequency oscillatory ventilation (HFOV)
Source: ClinicalTrials.gov (NCT05657795). StuddyBuddy aggregates publicly available trial information.