Volume Guarantee® or Volume-Controlled Ventilation, version 6
Research type
Research Study
Full title
A Randomised Controlled Trial Comparing Two Methods of Providing Volume-Targeted Ventilation in Preterm Infants with Respiratory Distress Syndrome: Volume Guarantee ® versus Volume-Controlled Ventilation
IRAS ID
121261
Contact name
Helen Chitty
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Research summary
This study compares two existing types of ventilation for premature babies born more than six weeks early who develop breathing difficulties shortly after birth. They are called Volume Guarantee® and Volume-Controlled ventilation. Both are used widely throughout the UK and worldwide. They are both safe and effective but have not been compared with each other in a clinical trial to see if one has any advantages over the other.
Premature babies often develop breathing difficulties (respiratory distress syndrome) shortly after birth due to the immaturity of their lungs. There are various treatments available for this according to each baby's needs. One treatment is to use an artificial breathing machine (a ventilator). A ventilator delivers a volume of gas (a mixture of air and oxygen) to the baby via a tube that is inserted into the baby's windpipe (an endotracheal tube).
Volume Guarantee® and Volume-Controlled ventilation aim to control the volume of gas that reaches the baby's lungs to keep it within a normal range. They do this in different ways. Volume Guarantee® makes breath-to-breath adjustments to the pressure that is generated whenever the ventilator delivers a volume of gas to the baby. These adjustments aim to keep that volume of gas within the normal range. In Volume-Controlled ventilation the doctor or nurse intermittently adjusts the overall set volume to aim to keep the volume of gas that reaches the baby within the normal range.
This study will be conducted in the Neonatal Unit at The James Cook University Hospital, Middlesbrough. Eligible babies are those born at <34 weeks’ gestation (six or more weeks early) who are admitted to the Neonatal Unit and require ventilation within the first 24 hours of life for breathing difficulties. Data collection will continue until all babies are discharged from hospital.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0182
Date of REC Opinion
20 Jun 2013
REC opinion
Favourable Opinion