Actively Recruiting

Phase Not Applicable
All Genders
NCT05030337

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here