Improving oxygen control in premature infants on mechanical ventilation
Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants
This study is testing if a new automated system for controlling oxygen can help premature infants on breathing machines do better than the usual manual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05030337 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to optimize oxygen delivery in premature infants requiring mechanical ventilation by comparing closed-loop automated oxygen control with manual oxygen control. The study will enroll at least seventy infants born before 31 weeks of gestation and will monitor their oxygen saturation levels using a specialized software called OxyGenie. Participants will be randomly assigned to either the automated or manual control group, and their clinical outcomes will be assessed to determine the effectiveness of the closed-loop system. The trial will also collect data on associated comorbidities that may affect ventilation duration.
Who should consider this trial
Good fit: Ideal candidates are premature infants born at less than 31 weeks gestation who require mechanical ventilation within the first 48 hours after birth.
Not a fit: Patients who may not benefit include those born at or above 31 weeks gestation and infants with major congenital abnormalities.
Why it matters
Potential benefit: If successful, this approach could reduce complications associated with mechanical ventilation and improve outcomes for premature infants.
How similar studies have performed: Previous studies have shown that closed-loop oxygen control can improve oxygen saturation management, but this specific approach is still being evaluated for its impact on clinical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Anne Greenough, Professor — King's College Hospital/ King's College London
- Study coordinator: Ourania Kaltsogianni, MSc
- Email: ourania.kaltsogianni@nhs.net
- Phone: (+44)02032999000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.