About one in seven babies born in the UK each year need specialist neonatal care in a hospital because they are born too early, are born very small or have a medical condition. Ensuring these babies have enough nutrition is a key part of their care.
Premature babies are fed milk every few hours through a soft plastic tube down into their stomach, called a 'gastric tube'. Because their stomachs and digestive systems are not yet ready for lots of milk, the amount of milk given each feed is increased slowly. Some doctors and nurses regularly check how much milk is left in a baby's stomach, called 'routinely measuring gastric residual volumes'. They check because they believe it will help them know how the baby is coping with the milk feeds and they also think it may help to identify a severe disease called necrotising enterocolitis (NEC). However, others think measuring gastric volumes may be unnecessary for babies and that it is inaccurate, uncomfortable for the baby and may actually be harmful.
We want to answer the question:
Is routinely measuring gastric residual volumes good or bad for babies?
1. How will we do this?
We will test whether not routinely measuring gastric residual volumes, compared to routinely measuring them, helps premature babies to get to full milk feeds quicker without more incidents of necrotising enterocolitis.
The trial will involve babies born more than 6 weeks early and will recruit about 7040 babies in total across the UK and Australia. Babies will be recruited from about 36 hospitals in the UK and 3-4 large hospitals in Australia, and will be recruited into one of two groups:
NO ROUTINE MEASUREMENT OF GASTRIC RESIDUAL VOLUMES
ROUTINE, UP TO 6 HOURLY, MEASUREMENT OF GASTRIC RESIDUAL VOLUMES
This will be decided by chance, and babies will have an equal chance of being in either group.
The two approaches being compared are already used in clinical practice across the UK and Australia, so there is nothing new about either type of care. Babies will stay in the study until they reach full feeds, get discharged home, or when they reach 4 weeks past their due date (whichever one comes first).
2. Who can participate?
All babies that are born 6 or more weeks early (before 34 weeks of pregnancy) who require tube feeding. The neoGASTRIC study is an opt-out study. Therefore, all eligible babies will take part unless a parent does not wish their baby to participate or there is a medical reason why.
3. What are the possible benefits and risks of participating?
Both clinical approaches being studied are currently routinely practiced in the UK and Australia and so we do not believe there are any additional risks or benefits of taking part in neoGASTRIC.
Not routinely measuring gastric residual volumes might lead to babies reaching full feeds quicker which might reduce the risk of infections – but we will only know this after we finish the neoGASTRIC study.
We do not think there will be a greater risk of necrotising enterocolitis (NEC) from not routinely measuring gastric residual volumes because countries that do not routinely do this, such as France, have similar amounts of necrotising enterocolitis in the UK. Doctors and nurses will continue to look for necrotising enterocolitis through standard care and regular checks.