Optimisation of neonatal ventilation
| ISRCTN | ISRCTN17041826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17041826 |
| Secondary identifying numbers | 20699 |
- Submission date
- 07/07/2016
- Registration date
- 11/07/2016
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
King's College London
Neonatal Unit
4th Floor
Golden Jubilee Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
 ORCID ID |
0000-0002-8672-5349 |
|---|---|
| Phone | +44 20 3299 9000 ext. 38492 |
| anne.greenough@kcl.ac.uk |
Study information
| Study design | Single-centre randomised cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Optimisation of neonatal ventilation - determining the appropriate level of volume guarantee |
| Study objectives | 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(s) | Ethics Board - South East Coast - Surrey Research Ethics Committee, 28/10/2015, ref: 15/LO/1414 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2015 |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 18; UK Sample Size: 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | 2. Infants born less than 32 weeks completed gestation 2. Remain ventilator dependent two weeks after birth |
| Key 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 |
| Date of first enrolment | 04/05/2016 |
| Date of final enrolment | 14/11/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE5 9RS
United Kingdom
Sponsor information
University/education
Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Research council
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- King's College, King's College London UK, KCL, King's
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 14/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 08/02/2019 | No | No | ||
| Results article | results | 01/01/2019 | 08/05/2019 | Yes | No |
| Protocol file | version 3.0 | 16/08/2016 | 10/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
10/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
08/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
14/02/2019: The following changes were made:
1. The inclusion criteria have been changed
2. The basic results of this trial have been uploaded as an additional file.
