NCT05030337 Optimising Ventilation in Preterms With Closed-loop Oxygen Control
| NCT ID | NCT05030337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College Hospital NHS Trust |
| Condition | Infant, Premature, Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-09-05 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2021-09-05 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Preterm infants above 31 weeks completed gestation or term born infants * Infants with major congenital abnormalities
Contact & Investigator
Anne Greenough, Professor
PRINCIPAL INVESTIGATOR
King's College Hospital/ King's College London
Frequently Asked Questions
Who can join the NCT05030337 clinical trial?
This trial is open to participants of all sexes, studying Infant, Premature, Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05030337 currently recruiting?
Yes, NCT05030337 is actively recruiting participants. Contact the research team at ourania.kaltsogianni@nhs.net for enrollment information.
Where is the NCT05030337 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05030337 clinical trial?
NCT05030337 is sponsored by King's College Hospital NHS Trust. The principal investigator is Anne Greenough, Professor at King's College Hospital/ King's College London. The trial plans to enroll 70 participants.