FiO2-C Trial
Research type
Research Study
Full title
Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety and efficacy
IRAS ID
317261
Contact name
Vrinda Nair
Contact email
Sponsor organisation
University Hospital Tuebingen
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 31 days
Research summary
Prematurely born babies especially less than 28 weeks, frequently experience low and high oxygen level episodes.The low oxygen episodes are primarily due to pauses in their breathing (Apnoea of prematurity) and immaturity of their lung. These episodes persist for weeks.. Observational data indicate that severe and prolonged low oxygen episodes are associated with severe eye disease, severe lung disease, bowel disease, poor development and death. Automatic control of the oxygen delivery to baby reduces time spent outside the oxygen target range for premature babies, decreases number and duration of high and low oxygen episodes. The proposed randomised controlled trial was designed to compare the effect of automatic oxygen control in addition to manual adjustments, in comparison with manual adjustments of oxygen delivery only, on death and severe complications of prematurity thought to be related to high and low oxygen levels and poor development in babies born early before 28 weeks of gestation. The main outcome will be a composite of death, severe eye disease, chronic lung disease, or necrotizing enterocolitis (bowel disease in premature babies) until a postmenstrual age of 36 weeks. Key secondary outcome variables are death or major developmental impairment determined at 2 years of age. The results of this trial may help to improve the quality of life of babies who are born less than 28 weeks and reduce the burden of significant health conditionas well as costs for health care and society
REC name
West of Scotland REC 1
REC reference
22/WS/0143
Date of REC Opinion
21 Nov 2022
REC opinion
Further Information Favourable Opinion