A pilot study to compare high versus low tidal volume for mechanical ventilation in preterm babies with respiratory distress syndrome
| ISRCTN | ISRCTN86307399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86307399 |
| IRAS number | 126072 |
| Secondary identifying numbers | IRAS Project ID: 126072 |
- Submission date
- 29/05/2014
- Registration date
- 14/08/2014
- Last edited
- 25/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Very premature babies (those of less than 32 weeks gestation or weighing less than 1500g) are born with lungs that have not yet fully developed. These babies may need help to breathe with the support of machines (mechanical ventilation) until their lungs are developed enough to do the work on their own. Traditionally, mechanical ventilation has been provided by controlling the pressure or volume of air delivered by these machines (ventilators). Recent studies have shown that controlling the volume works better than controlling pressure and has fewer side effects. The volume controlled ventilation works by controlling the amount of air/oxygen delivered at each breath (tidal volume). However, the tidal volume delivered by ventilators in clinical practice varies considerably, from 4-8ml/kg. This is important as, although lower tidal volumes can prevent the lungs from being damaged, they can also make the baby work harder at their breathing than they should. Some new advances in the technology means that there are now better ventilators that can deliver more accurate tidal volumes than before. We have therefore decided to take a closer look at what may be the best tidal volume to use in terms of performance and preventing side effects. Here, we are comparing the effects of the lower end of what is considered a normal tidal volume (4-5 ml/kg) to those of a higher normal tidal volume (7-8 ml/kg) delivered by mechanical ventilation to premature babies.
Who can participate?
Premature babies needing mechanical ventilation, weighing between 500-1500g or of no more than 32 weeks gestation at birth.
What does the study involve?
The babies are randomly allocated into one of two groups. Those in group 1 are given the lower normal tidal volume of air (4-5 ml/kg) via mechanical ventilation. Those in group 2 are given the higher normal tidal volume of air (7-8 ml/kg). We then compare the two groups to see which babies come of the ventilator first.
What are the possible benefits and risks of participating?
Not provided at registration.
Where is the study run from?
University Hospital of North Tees (UK)
When is the study starting and how long is it expected to run for?
July 2013 to February 2015
Who is funding the study?
North Tees and Hartlepool Hospitals NHS Foundation Trust (UK)
Who is the main contact?
Prof Samir Gupta
samir.gupta@nth.nhs.uk
Contact information
Scientific
Consultant Neonatologist
Department of Paediatrics
University Hospital of North Tees
Hardwick Road
Stockton on Tees
TS19 8PE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled 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 | HILO Trial - A comparative pilot study of HIgh versus LOw tidal volume for mechanical ventilation in very low birth weight preterm babies with respiratory distress syndrome. A randomised controlled trial |
| Study acronym | HILO Trial |
| Study objectives | The time to achieve a 25% reduction in peak pressure in very premature babies receiving mechanical breathing support using volume-targeted ventilation is less using high normal tidal volume (7-8 ml/kg) as compared to low normal tidal volume (4-5 ml/kg). Null hypothesis: There is no difference in time to achieve 25% reduction in peak pressure using either 7-8 ml/kg or 4-5 ml/kg tidal volume. |
| Ethics approval(s) | Sunderland Ethics Committee; ref. 13/NE/0110 |
| Health condition(s) or problem(s) studied | Respiratory distress syndrome |
| Intervention | The study would involve randomising the babies to low tidal volume (4-5 ml/kg) or high tidal volume (7-8 ml/kg) at birth using volume guarantee mode of ventilation. We would also collect tracheal aspirate before surfactant. The babies would then have a standard management on ventilation without altering the tidal volume. |
| Intervention type | Other |
| Primary outcome measure | The time to achieve 25% reduction in peak pressure |
| Secondary outcome measures | 1. Duration of intubation 2.Incidence of pulmonary and non-pulmonary complications i.e., pneumothorax, bronchopulmonary dyplasia, intraventricular haemorrhage 3. Impact on inflammatory markers in tracheal aspirate 4. Survival to discharge |
| Overall study start date | 18/07/2013 |
| Completion date | 28/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 70 |
| Key inclusion criteria | 1. Preterm babies weighing 500-1500g or ≤32 weeks of gestation at birth 2. Requirement of intubation and mechanical ventilation |
| Key exclusion criteria | 1. Serious underlying congenital anomaly 1.1. Congenital diaphragmatic hernia 1.2. Cyanotic congenital heart disease 1.3. Airway anomalies 1.4. Abdominal wall defects 2. Multiple pregnancies only the first-born were enrolled and randomized; the others received the same strategy but were not be enrolled 3. Babies initiated on ventilation after 12 hours of life or transferred from other centres |
| Date of first enrolment | 18/07/2013 |
| Date of final enrolment | 28/02/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TS19 8PE
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Jane Greenaway
Research and development Manager
Hardwick Road
Stockton on Tees
TS19 8PE
England
United Kingdom
"ROR" |
https://ror.org/04zzrht05 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2019 thesis in http://etheses.dur.ac.uk/13320/ (added 25/06/2020) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/06/2020: Link to thesis added to publication and dissemination plan.
18/04/2017: No publications found in PubMed, verifying study status with principal investigator.
