Optimising newborn nutrition during therapeutic hypothermia: an observational study using routinely collected data

Every year about 1200 babies in England, Wales and Scotland suffer from a lack of oxygen around birth which can lead to long-term brain injury or death This is called Hypoxic Ischaemic Encephalopathy (HIE) Research has shown that cooling babies with HIE by a few degrees for the first 3 days protects the brain; all babies with moderate or severe HIE in the UK are treated with therapeutic hypothermia (cooling) Doctors do not know how best to care for babies while they are cooled A key question is how to provide nutrition to babies during cooling There are two main parts to this question, milk feeds ( enteral nutrition) and intravenous nutrition ( parenteral nutrition) We don't know how best to provide either milk or intravenous nutrition to cooled babies - MILK FEEDS: Some neonatal units in the UK carefully feed babies (usually with maternal breast milk) while they are cooled This avoids intravenous lines and is believed to help them feed and go home earlier Other neonatal units do not feed cooled babies because they worry about a condition called necrotising enterocolitis (a devastating and often fatal disease) which might be more common with feeding - INTRAVENOUS NUTRITION: All cooled babies need intravenous fluid (even when milk feeds are given it takes several days before enough fluid can be given this way) Some neonatal units give babies intravenous nutrition (which contains fat, protein, carbohydrate, vitamins and minerals) as this may improve growth and recovery Other neonatal units only give intravenous dextrose with simple salts because of concerns that intravenous nutrition leads to more infections This study will compare these different ways of providing nutrition It will use a research database called the National Neonatal Research Database (NNRD) In England, Scotland and Wales doctors and nurses looking after babies in neonatal care (including all cooled babies) use an Electronic Health Record system Data from this system are anonymised (no baby can be identified) and form the NNRD, so the NNRD holds data from all babies who have been looked after on NHS neonatal units We have worked closely with parents and charities in developing the NNRD We will use the NNRD to study all term babies who received cooling in England, Scotland and Wales since 2008 We will compare the milk feeding and intravenous nutrition they receive - MILK FEEDING: We will compare babies who are fed milk while cooled with those that are not fed any milk Our main goal is to establish whether there is any difference in rates of necrotising enterocolitis - INTRAVENOUS NUTRITION: We will compare babies who get intravenous nutrition with those that only get intravenous dextrose The main difference we are looking for is in the rate of infection We will also study how many babies die, how long they stay in neonatal care, how soon breastfeeding starts and many are breastfed when they go home We will apply a statistical approach called potential outcomes framework in which babies are matched in each group (eg babies who are fed and those who are not fed) as closely as possible This will ensure that any difference in outcomes is due to the different nutritional treatments and not due to background differences or other confounders (like how sick a baby is) The results from this study will help to ensure that babies who need to be cooled for HIE receive the best and safest nutrition in the future