Plain English Summary
Background and study aims
Premature babies are at high risk of developing breathing problems because their lungs are not fully matured when they are born. The use of mechanical ventilation (breathing machine) is life saving for these children, however it can also damage the lungs, leading to long-term breathing problems or dependence on receiving oxygen (bronchopulmonary dysplasia). New forms of breathing support for newborn babies have been developed with the aim of minimising lung damage. One of these new forms, called volume targeted ventilation (VTV), delivers the same size of inflation (mechanical breath) to the baby despite changes in their lung function. Previous studies in both prematurely and term-born infants that larger rather than smaller mechanical breaths appear to reduce the breathing effort required from the baby. However it is no known what size of inflation is best for the growing population of prematurely born infants with developing or established bronchopulmonary, who may remain on the breathing machine for many months. The aim of this study is to assess how hard premature babies on breathing support are working to breathe when receiving different breath volumes (sizes) via the ventilator (within the normal baby breathing range).
Who can participate?
Infants born at least eight weeks early who rely on breathing machines two weeks after birth.
What does the study involve?
Each baby has a small catheter (thin flexible tube) placed to measure how hard the baby is working to breathe. The babies then receive four different sizes of breath for 20 minutes in a random order, with 20 minutes in between (during which they receive their normal size breaths from the ventilator). The work or breathing is measured for the last 5 minutes of each period. The whole study takes around 3 hours, after which the catheter is removed. The best mechanical breath size is determined by the level at which the baby has the lowest work of breathing.
What are the possible benefits and risks of participating?
There are no direct benefits to participants taking part in this study. There is a small risk of slight discomfort for participants when the catheter is placed and removed.
Where is the study run from?
King's College Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2015 to February 2018
Who is funding the study?
1. Biomedical Research Council (UK)
2. Kings College London (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
King's College London
Neonatal Unit
4th Floor
Golden Jubilee Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 20 3299 9000 ext. 38492
anne.greenough@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20699
Study information
Scientific title
Optimisation of neonatal ventilation - determining the appropriate level of volume guarantee
Acronym
Study hypothesis
The aim of this study is to determine which level of volume targetting will best reduce the work of breathing in ventilated infants with evolving or established bronchopulmonary dysplasia.
Ethics approval
Ethics Board - South East Coast - Surrey Research Ethics Committee, 28/10/2015, ref: 15/LO/1414
Study design
Single-centre randomised cross over trial
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
Specialty: Children, Primary sub-specialty: Neonatal
Intervention
Participants are ventilated infants who are randomised to receive targeted tidal volume of 4,5,6, and 7ml in a random order for 20 minutes, with a 20 minute 'washout period' of their baseline settings in between. A dual tipped pressure transducer catheter is inserted at the beginning of the study (similar to a feeding tube) and used to record the pressure-time product of the diaphragm for the last 5 minutes of each 20 minute period. The study lasts for around 3 hours in total.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Work of breathing, measured as the pressure-time product of the diaphragm, during the last 5 minutes of each 20 minute period at different levels of volume targeting.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2015
Overall trial end date
28/02/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
2. Infants born less than 32 weeks completed gestation
2. Remain ventilator dependent two weeks after birth
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 18; UK Sample Size: 18
Total final enrolment
18
Participant exclusion criteria
1. Infants born above 32 weeks of gestational age
2. Infants who have been successfully extubated by two weeks age
3. Complex congenital cardiac abnormalities
4. Congenital diaphragmatic hernia
Recruitment start date
04/05/2016
Recruitment end date
14/11/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Funders
Funder type
Research council
Funder name
Biomedical Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kings College London
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
14/11/2018
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN17041826_Basic results_08Feb19.pdf
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/29305407 (added 08/05/2019)