Speed of Increasing milk Feeds Trial (SIFT)

Survival of preterm infants has increased greatly over recent years, so a major aim now is to improve the long-term outlook for these babies and to avoid serious complications Over 8000 babies are born very prematurely (more than 8 weeks before their due date) in the UK each year so this is an important issue for the NHS The way babies are fed in early life affects short and long-term health and survival, parental experience and access to their infants, health care associated costs, and the availability of neonatal intensive care space Because the bowels of premature babies have not matured, they cannot digest large volumes of milk feeds straight away Until the gut matures, nutrition is provided by intravenous (iv) drip while the amount of milk feed is gradually increased over time Increasing the amount of milk rapidly may increase the risk of serious or life-threatening gut complications On the other hand, increasing slowly means that iv nutrition is needed for longer As this can only be given down intravenous lines, there is an associated increase in the number of infections proportional to the number of days the line is present in the bloodstream of these babies Infection is a common cause of death and disease affecting just over a quarter of very low birthweight preterm babies in the UK, and these and gut complications cause more than one third of all deaths in preterm babies who survive their first week of life Infection or necrotising enterocolitis (NEC), where portions of the bowel undergo necrosis (tissue death), also double the risk of poor long-term outcome for preterm infants Intravenous feeding also contributes to liver damage, vitamin, salt and nutrition imbalances Providing iv nutrition safely and effectively is complicated and a recent large NHS confidential enquiry showed that only a quarter of all preterm infants had their iv feeding managed optimally Recent surveys show large variations between units in intravenous feeding and milk feeding practices and it is therefore clear that doctors currently do not agree on the best way to deal with this Despite the universal importance of milk feeding preterm babies, there have been very few studies to help doctors learn how best to balance these risks, and what the best way to increase feeds in these babies is - this study sets out to address this missing information We will compare two different daily rates of increase in milk feeds, one 'fast' and one 'slow', but both within the rates currently used in UK neonatal units We aim to find out if either rate gives better outcomes for the infants We will measure a variety of important outcomes, such as survival, infection, bowel problems, growth and long-term physical and mental development, as well as the impacts on families and the NHS including costs Increasing feed volumes more quickly may mean babies and their parents need to stay in hospital for less time and could mean that more babies are able to be cared for in the neonatal intensive care unit closest to home, something very important to families This study will be led by an experienced team of doctors and researchers who have run similar studies before, and will use an established network of neonatal units that have taken part in previous studies We are confident that there will be enough families happy to take part in the study The costs requested will support clinical teams to recruit babies, record data and collect outcome information A clinical trials unit that has helped develop the trial will plan and set up the trial, create and maintain necessary databases, implement web-based randomisation (allocation of babies to either fast or slow increases in their feeds), provide ongoing monitoring and support, perform data analysis, support trial monitoring committees, and contribute to release of the results The study requires ethics approval, but will compare strategies already in current use so we do not anticipate any problems with this Importantly parents and patient representatives have been involved in the design phase of the study and will be represented on the monitoring committees