Condition category
Respiratory
Date applied
29/10/2018
Date assigned
01/11/2018
Last edited
28/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many prematurely born infants, and a small number of those born at term, will require help with their breathing in the newborn period. A breathing tube connected to a ventilator (mechanical ventilation) can be life saving, but unfortunately it can be associated with long-term complications. The most common of these adverse outcomes is chronic lung disease, yet infants can also have neurological problems at follow up and may develop cerebral palsy. These complications are increased in infants who have suffered abnormalities in their carbon dioxide levels. Therefore, if we are to improve the outcomes of infants requiring breathing support in the newborn period, it is vital that we can appropriately and safely monitor these levels. By having a real time continuous reading of carbon dioxide we aim to be able to reduce the number of acute complications of respiratory support by allowing earlier detection of blocked or dislodged breathing tubes. We also aim to be able to reduce the number of invasive blood tests performed, which would normally be used to monitor carbon dioxide levels when continuous monitoring is not available. Finally by having continual monitoring of carbon dioxide levels available we aim to be able to regulate these values more closely to avoid levels that are either too high, or too low, the results of which may lead to the adverse outcomes mentioned above.

Who can participate?
Newborns requiring invasive mechanical ventilation within the newborn period

What does the study involve?
The research team will be approaching parents within the first day of admission to the neonatal unit to discuss the study and obtain informed written consent if parents wish for their baby to take part. The study will involve inserting a small CE marked device into the routine ventilator circuit so that the levels of carbon dioxide produced can be continuously monitored.

What are the possible benefits and risks of participating?
This device is aimed at improving newborn safety whilst infants are receiving life saving breathing support, therefore participants may benefit from the use of this device. As this study is non invasive and uses a CE trademarked device, there are no known risks to participants taking part.

Where is the study run from?
King’s College Hospital Neonatal Unit, London (UK)

When is the study starting and how long is it expected to run for?
October 2018 to August 2020

Who is funding the study?
1. The Charles Wolfson Charitable Trust (UK)
2. SLE Ltd (UK)

Who is the main contact?
Professor Anne Greenough
anne.greenough@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anne Greenough

ORCID ID

http://orcid.org/0000-0002-8672-5349

Contact details

4th Floor Golden Jubilee Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 3037
anne.greenough@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39771

Study information

Scientific title

Optimising mechanical ventilation in newborns using capnography

Acronym

Study hypothesis

1. Using end tidal capnography will allow earlier detection of acute complications in mechanically ventilated infants such as blocked or dislodged endotracheal tubes.
2. End tidal capnography will reduce the average daily frequency of invasive blood sampling and hence the associated complications related to blood transfusions.
3. Using side stream capnography to provide continuous monitoring will reduce the time spent with abnormal carbon dioxide levels and the development of serious complications such as bronchopulmonary dysplasia, intraventricular haemorrhage and periventricular leukomalacia.
4. Accurate calculation of anatomical and alveolar dead space in infants with various neonatal respiratory diseases using real time capnography will allow appropriate tidal volumes to be delivered in different respiratory conditions.

Ethics approval

London-Camden & Kings Cross Research Ethics Committee, favourable opinion on 10/10/18, final approval pending, REC ref: 18/LO/1602

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Children, Primary sub-specialty: Neonatal; Health Category: Respiratory

Intervention

A side stream capnograph will be integrated with the ventilator circuit for the whole time the infant is receiving invasive mechanical ventilation. In order to validate the side steam capnography against the gold standard mainstream capnography, the NM3 mainstream capnograph will be incorporated into the ventilator circuit for a 20 minute period.
Infants will have routine neonatal follow up as per the clinical team and no follow up specific to the research being carried out is required.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Decrease in the complications of mechanical ventilation and decrease in the frequency of blood sampling in ventilated newborn infants.; Timepoint(s): .
The following are recorded throughout the period the infant is receiving invasive mechanical ventilation:
1. Frequency of complications of mechanical ventilation (pneumothorax, blocked or dislodged endotracheal tube, hypo or hypercarbia),
2. Frequency of routine blood gas sampling
These will be compared to historical controls who were invasively mechanically ventilated prior to the use of routine end tidal capnography monitoring.

Secondary outcome measures

1. Validation of side stream capnography with mainstream capnography and arterial carbon dioxide levels, ascertained by correlation of values in kPa during a twenty-minute validation period
2. Anatomical and alveolar dead space, calculated in mechanically ventilated infants with four neonatal respiratory conditions:
2.1. Respiratory distress syndrome
2.2. Evolving bronchopulmonary dysplasia
2.3. Meconium aspiration syndrome
2.4. Persistent pulmonary hypertension of the newborn
These will be calculated by analysing carbon dioxide waveforms using the Bohr/Enghoff equation once the infant is no longer receiving mechanical ventilation.

Overall trial start date

01/10/2018

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Neonates
2. Invasively mechanically ventilated
3. Admitted to the neonatal intensive care unit
4. Written parental consent

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Non ventilated infants
2. Infants on non-invasive respiratory support

Recruitment start date

28/11/2018

Recruitment end date

01/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal Intensive Care Unit
4th Floor Golden Jubilee Wing King's College Hospital Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital

Sponsor details

R&D Manager
King's College Hospital NHS Foundation Trust
161 Denmark Hill
London
SE5 8EF
United Kingdom
+44 (0)20 3299 3841
Kch-tr.research@nhs.net

Sponsor type

Hospital/treatment centre

Website

Organisation

King's College London

Sponsor details

Director of Research Management and Directory of Administration
King's College London
Room 5.31
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)207 848 3224
susan.dickson@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Charles Wolfson Charitable Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

SLE LIMITED

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. Results are intended to be published one year after the completion of the trial. Results will also be presented at national and international conferences.

IPD sharing statement:
The datasets analysed will be expected to be included in the subsequent results publication but full data sharing plans for the current study are not currently known and will be made available at a later date.

Intention to publish date

31/08/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/11/2018: The recruitment start date has been changed from 14/11/2018 to 28/11/2018. 02/11/2018: Internal review.