HILO Trial
Research type
Research Study
Full title
High vs. Low Tidal Volume for Mechanical Ventilation in Preterm Babies with respiratory distress syndrome - A randomised controlled trial
IRAS ID
126072
Contact name
Samir Gupta
Contact email
Sponsor organisation
University Hospital of North Tees and Hartlepool NHS Foundation Trust
Research summary
Very small premature babies (<32 weeks or weighing less than 1500g) are born with immature lungs and can require support for breathing with the help of machines (mechanical ventilation). Traditionally it has been provided by controlling the pressure or volume delivered by these machines (ventilators). Recent studies have demonstrated that targeting volume is better in terms of its efficacy while reducing the incidence of side effects.
The volume controlled ventilation works on the principle of controlling tidal volume (volume delivered at each breath). Various studies have shown that a wide range of tidal volumes (4-8ml/kg) are used in practice. While lower tidal volumes could limit volutrauma (damage to lungs due to over-distension), there are studies suggesting that such low tidal volumes in turn can lead to increased work of breathing. High tidal volumes could in turn limit atelectotrauma (damage to the lungs due to under-distension).
With the advances in technology, we have now better modes of ventilation which are much better at delivering the precise volume that their predecessors. These have re-drawn our attention to which is better tidal volume in terms of its efficacy and side effects.
IN this pilot study we would randomly assign the babies in the normal range of tidal volume currently practised (4-8ml/kg). The study would allow comparing low normal (4-5ml/kg) to high normal (7-8ml/kg) volumes of gas given by the breathing machine earlier. The machine needs higher pressure to drive the gas in the beginning which gradually comes down as the lungs improve. Once the pressures are below a certain point, the babies are considered to be suitable to come off the machine. Hence we can objectively measure the difference between the two groups by comparing the time required for reduction in pressure requirement by 25%.
We would also measure the timetable to exudate (i.e. when the baby would be off the breathing support through the machine), inflammatory markers in the lungs, short term outcomes like chronic lung disease and death before discharge.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0110
Date of REC Opinion
22 May 2013
REC opinion
Further Information Favourable Opinion