Optimising Ventilation in Preterms With Closed-loop Oxygen Control

Recruiting now · Not applicable

Conditions studied: Infant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation Complication

In brief

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.

Key facts

Study ID

NCT05030337

Run by

King's College Hospital NHS Trust

People needed

70

Starts

2021-09-05

Expected to finish

2025-03-01

Last updated by the study team

2024-10-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• Preterm infants above 31 weeks completed gestation or term born infants
• Infants with major congenital abnormalities

Where it is running

• King's College Hospital NHS Foundation Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.