Plain English Summary
Background and study aims
Oxygen therapy is common in newborn babies requiring intensive care. Whilst having too little oxygen can increase the risk of death or disability, too much oxygen can cause injury to the eyes, lungs and brain. Hence it is important to maintain oxygen levels in blood (saturation) within a target range. Studies show that it is possible to maintain saturation levels within the target range for about 50% of the time through manual adjustment of oxygen at the bedside. It is now possible to use an automated device to manage this. Its safety, feasibility and effectiveness is proven. We wish to investigate its relative effectiveness in the newborn population.
Who can participate?
Preterm infants receiving mechanical ventilation requiring supplemental oxygen therapy.
What does the study involve?
Over a 24-hour period each baby will have their oxygen levels maintained with manual adjustment for 12 hours and automated adjustment for 12 hours . The duration of time that the babies' oxygen saturation remains within the target range will be compared in the two periods.
What are the possible benefits and risks of participating?
All treatment and care of such babies will remain exactly the same as is our standard.
Where is the study run from?
Neonatal Intensive Care Unit, The James Cook University Hospital (UK).
When is the study starting and how long is it expected to run for?
From September 2011 to August 2013.
Who is funding the study?
Investigator initiated and funded (UK).
Who is the main contact?
Dr Mithilesh Lal
Trial website
Contact information
Type
Public
Primary contact
Dr Mithilesh Lal
ORCID ID
http://orcid.org/0000-0002-9156-229X
Contact details
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3.0 / 19 September 2011
Study information
Scientific title
Efficacy of automated control of inspired oxygen in ventilated preterm infants: a randomized control trial
Acronym
CLIO-RCT
Study hypothesis
The objective of this study is to evaluate the efficacy of the automatic FiO2 control function in comparison to manual FiO2 control during routine care in maintaining target range of SpO2 between 90 to 95% using a randomized crossover design in ventilated preterm infants requiring supplemental oxygen therapy.
We hypothesized that there would be no difference between the automated and manual control periods in the primary outcome variable defined as the proportion of time with SpO2 within the assigned target range of 90-95% plus time with SpO2 above the assigned target range in room air.
The safety null hypothesis of this study was that there would be no difference between automated and manual control periods in the proportion of time in severe hypoxemia defined as SpO2 < 80% and severe hyperoxemia defined as SpO2 ≥ 98%, when not in room air.
Ethics approval
National Research Ethics Service (NRES) Committee North East - County Durham & Tees Valley UK, 23/11/2011, ref: 11/NE/0302
Study design
Single-centre physiological crossover study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Respiratory failure in preterm infants requiring mechanical ventilation
Intervention
This randomized crossover trial involved preterm infants who are mechanically ventilated and receiving supplemental oxygen. Each infant was studied for two consecutive 12-hour periods, one with inspired oxygen (FiO2) adjustment by the clinical team (manual) and the other by an automated device (CLIO) (automated), assigned in a random sequence.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Proportion of time with pulse oximetry (SpO2) within the assigned target range of 90-95% during two consecutive 12-hour periods of automated and manual adjustment of inspired oxygen (FiO2).
Secondary outcome measures
Proportion of time with pulse oximetry (SpO2) outside of the assigned target range of 90-95%, extreme hypoxemia (<80%) and hyperoxemia (≥98%) during two consecutive 12-hour periods of automated and manual adjustment of inspired oxygen (FiO2).
Overall trial start date
19/09/2011
Overall trial end date
31/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Preterm infants were enrolled in the study if they met all of the following inclusion criteria:
1. Written informed parental consent
2. Receiving mechanical ventilation through an endotracheal tube
3. On supplemental oxygen at the time of enrolment and during the previous 24 hours
4. Without major congenital anomalies
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Major congenital anomalies
2. Not requiring supplemental oxygen during the previous 24 hours prior to enrollment.
Recruitment start date
30/01/2012
Recruitment end date
31/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Neonatal Intensive Care Unit, The James Cook University Hospital
Marton Road
Middlesbrough
TS7 0LT
United Kingdom
Sponsor information
Organisation
South Tees Hospital NHS Trust
Sponsor details
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26194933