Automated adjustment of inspired oxygen in premature infants requiring mechanical ventilation

ISRCTN ISRCTN94119947
DOI https://doi.org/10.1186/ISRCTN94119947
Secondary identifying numbers Version 3.0 / 19 September 2011
Submission date
18/03/2015
Registration date
23/03/2015
Last edited
01/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mithilesh Lal
Public

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

ORCiD logoORCID ID 0000-0002-9156-229X

Study information

Study designSingle-centre physiological crossover study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleEfficacy of automated control of inspired oxygen in ventilated preterm infants: a randomized control trial
Study acronymCLIO-RCT
Study objectivesThe 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(s)National Research Ethics Service (NRES) Committee North East - County Durham & Tees Valley UK, 23/11/2011, ref: 11/NE/0302
Health condition(s) or problem(s) studiedRespiratory failure in preterm infants requiring mechanical ventilation
InterventionThis 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureProportion 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 measuresProportion 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 study start date19/09/2011
Completion date31/08/2013

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants30
Key inclusion criteriaPreterm 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
Key exclusion criteria1. Major congenital anomalies
2. Not requiring supplemental oxygen during the previous 24 hours prior to enrollment.
Date of first enrolment30/01/2012
Date of final enrolment31/08/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Neonatal Intensive Care Unit, The James Cook University Hospital
Marton Road
Middlesbrough
TS7 0LT
United Kingdom

Sponsor information

South Tees Hospital NHS Trust
Hospital/treatment centre

Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom

Website www.southtees.nhs.uk
ROR logo "ROR" https://ror.org/02js17r36

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2015 Yes No

Editorial Notes

01/09/2016: Publication reference added.