Condition category
Neonatal Diseases
Date applied
18/03/2015
Date assigned
23/03/2015
Last edited
01/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.southtees.nhs.uk

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26194933

Publication citations

Additional files

Editorial Notes

01/09/2016: Publication reference added.