Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRAS Project ID: 126072
Study information
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
Acronym
HILO Trial
Study hypothesis
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
Sunderland Ethics Committee; ref. 13/NE/0110
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled 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 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
Phase
Not Applicable
Drug names
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 trial start date
18/07/2013
Overall trial end date
28/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Preterm babies weighing 500-1500g or ≤32 weeks of gestation at birth
2. Requirement of intubation and mechanical ventilation
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
70
Participant 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
Recruitment start date
18/07/2013
Recruitment end date
28/02/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Neonatologist
Stockton on Tees
TS19 8PE
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
North Tees and Hartlepool Hospitals NHS Foundation Trust (UK); ref.: CH-087
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list