A large clinical trial involving around 40 hospitals in the UK is to investigate the best way to feed babies who are born between 10 and 7 weeks prematurely.
The £1.6 million NIHR-funded study will test two methods of feeding these premature babies to gather evidence on whether introducing milk at the earliest opportunity could benefit both the baby and their family.
The FEED1 trial is led by neonatal experts at the University of Nottingham and University Hospitals of Derby and Burton NHS Foundation Trust (UHDB) with support from Bliss, the leading charity for babies born premature or sick. The research will be managed by the Nottingham Clinical Trials Unit and will involve around 2,000 babies born between 30 and 33 weeks and their parents over the next 4½ years.
Around 8% of babies in the UK are born prematurely and of these 12% are born between 30 and 33 weeks into the pregnancy. Currently most premature babies are fed through a drip into a vein and when stable are only given small amounts of milk by a feeding tube into their stomach. The milk is slowly increased until they are fully milk fed.
Neonatal doctors have traditionally been wary of feeding premature babies with full milk straight after birth because of a potentially life-threatening gut condition called necrotising enterocolitis (NEC). Previous evidence suggests that in babies who are in a stable condition, larger milk feeds can be successfully given within 48 hours of birth without increasing the risk of NEC and this could reduce the risk of severe infection.
Leading the work, Dr Shalini Ojha, Associate Professor of Neonatology at the University of Nottingham and Neonatal Consultant at UHDB, said: “We want to find out if babies born between 30 and 33 weeks can be safely fully milk fed from the day they are born and if avoiding giving them fluids through a drip (intravenously) can reduce infections and help them go home sooner. We also aim to help mothers to start expressing breast milk as soon as possible after the birth. We will give this milk to the baby first and then give extra milk if needed. The type of milk we use will be the mother’s decision with staff guidance, but any mother’s breast milk will always be given first.”
“We also want to gather more robust evidence about the risk of infection and gut problems in babies who have earlier milk feeding. Simultaneously, we will find out more about parents’ feelings about how their baby is fed and the impact of premature birth on breast-feeding. The impact of this early milk feeding for premature babies on how neonatal services are delivered and the cost of care will also be explored in collaboration with health economists at the University of Warwick.”
Introducing milk feeds earlier in this group of babies who are relatively stable could have many benefits including the nutrients and protective antibodies of breast milk, as well as allowing closer bonding that comes with near-immediate contact and care from the parents. It could mean the families can be reunited sooner and it may reduce the demand for neonatal cots which are in short supply.
Parents who agree for their babies to be included in the research and who fall into the gestation category will either receive normal feeding intravenously from birth and gradual introduction of milk feeds at a later stage, or to receive milk feeds via a feeding tube into their tummies from birth. In order for the clinical trial to be a fair test, neither parents or doctors will be able to choose which method of feeding their baby receives – instead this will be chosen random by a computer. The amount of milk given will be increased over a few days and the babies in this group will get all of their fluids as milk, unless they are struggling with this and showing signs of sickness.
Caroline Lee-Davey, Chief Executive of the premature and sick baby charity Bliss, said: “We are thrilled to be supporting this pioneering research. We hope this study will provide further evidence about the best approach to feeding premature babies born between 30 and 33 weeks, to improve outcomes for these most vulnerable babies.”
The research team also includes parents who have had premature babies, like Charlotte Kenyon from Nottingham, who said: “I had a baby at 31 weeks and think that research trials like this are so important. I’m both proud and pleased to be involved especially if it helps another baby. As a parent being part of something like this means that we are thought about and listened to, research isn’t just about the science.”
The FEED1 trial also involves teams at the Dalhousie University Nova Scotia, Canada, University of York, Bradford Teaching Hospitals NHS Foundation Trust, Imperial College London, University Hospital Southampton NHS Foundation Trust and the University of Warwick.