Title: The neoGASTRIC trial: Avoiding routine gastric residual volume measurement in neonatal critical care, a multi-centre, randomised controlled trial
Funder: Department of Health and Social Care

Abstract: AIMS_x000D_ The neoGASTRIC trial will see if premature babies can safely get to full milk feeds more quickly_x000D_ _x000D_ BACKGROUND_x000D_ Premature babies are fed milk every few hours through a soft plastic tube into their stomach, a ‘gastric tube’, as they can’t effectively suck and swallow. They also can’t tolerate lots of milk soon after birth, so the amount of milk given at each feed is increased slowly while they get fluid or nutrition into the vein (intravenously). _x000D_ _x000D_ Some doctors and nurses regularly check how much milk is left in a baby’s stomach, called ‘routinely measuring gastric residual volumes’. Some doctors and nurses believe this helps tell if the baby is tolerating their feeds and may help identify a severe disease called necrotising enterocolitis. However, routinely measuring gastric residual volumes may also be bad for babies: it is inaccurate, may be uncomfortable and harmful because it can lead to feeds being stopped, which in turn can lead to more intravenous nutrition and problems like infection. Over 20,000 premature babies have gastric residual volumes routinely measured each year in the UK and Australia._x000D_ _x000D_ Doctors and nurses are unsure whether routine measuring of gastric residual volumes is good or bad for premature babies. NeoGASTRIC will answer this question by testing whether not routinely measuring gastric residual volumes, compared to routinely measuring them, helps premature babies to get to full milk feeds quicker without more necrotising enterocolitis. We will also test to see if there are other benefits like fewer infections or going home earlier from the neonatal unit. _x000D_ _x000D_ DESIGN AND METHODS USED_x000D_ To answer this research question we will use a randomised controlled trial: premature babies will either have no routine gastric residual volumes measured, or have gastric residual volumes measured regularly. This will be decided by chance: babies will have an equal chance of being in either group. NeoGASTRIC will involve babies born more than 6 weeks early (before 34 weeks). _x000D_ _x000D_ The two approaches being compared are already used across the UK and Australia, so there is nothing new about either type of care. NeoGASTRIC will therefore use an ‘opt-out’ style of consent, designed with parents to be as simple as possible for families. Parents will be informed about neoGASTRIC through posters and leaflets on the neonatal unit. Doing it this way means being in the trial is normal and usual, with all babies involved unless parents opt not to take part. This will make it easier for parents to be involved in the research and involve families who might not normally take part in research. To answer this question, we need to recruit about 7000 premature babies from about 36 hospitals in the UK. We also plan to run neoGASTRIC in 3-4 large hospitals in Australia to recruit more premature babies and ensure that the results improve neonatal care internationally._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT_x000D_ We worked with parents, ex-premature adults, and health professionals to design neoGASTRIC. This included opt-out consent, which babies should be included and what outcomes are most important. A parent advisory group will ensure that parent and patient views remain at the centre of the trial._x000D_ _x000D_ DISSEMINATION_x000D_ We will communicate the neoGASTRIC results through research journals, conferences, social media and virtual conferences for parents and for health professionals; we will use parent information material designed by parents

Lay abstract: RESEARCH QUESTION: In preterm infants (Population), does not routinely measuring gastric residual volumes (Intervention), compared with routine up to 6 hourly measurement of gastric residual volumes (Comparator), lead to shorter time to full enteral feeds without increasing necrotising enterocolitis (Outcomes)?_x000D_ _x000D_ BACKGROUND: Routine measurement of gastric residual volumes involves regularly aspirating the entire stomach contents to assess the volume and colour of the ‘aspirate’. It is established practice in many UK and Australian neonatal units for babies receiving gastric tube feeds. The rationale is to inform feeding decisions, assess ‘feed intolerance’ and to predict and potentially prevent necrotising enterocolitis, a serious gut condition. Evidence to support routine measurement of gastric residuals is poor and previous small trials are not generalisable to UK or Australian neonatal care. Previous work found that a trial is feasible and acceptable to parents and healthcare professional, and informed trial design._x000D_ _x000D_ AIMS: To test whether avoiding routine measurement of gastric residual volumes in preterm infants reduces the time taken for a baby to reach full enteral feeds without increasing harms – specifically necrotising enterocolitis_x000D_ _x000D_ METHODS: An individually randomised, controlled, unblinded, trial comparing two parallel care pathways, with an internal pilot and process evaluation_x000D_ _x000D_ POPULATION: Preterm infants admitted to participating UK or Australian neonatal units_x000D_ _x000D_ ELIGIBILITY_x000D_ Inclusion criteria: Preterm birth <34+0 gestational weeks+days; within 24 hours of starting feeds (receiving >15 ml/kg/day)_x000D_ Exclusion criteria: Nasogastric tube or orogastric not required; gastrointestinal surgical condition; major congenital abnormality_x000D_ _x000D_ CARE PATHWAYS TO BE COMPARED_x000D_ 1. No routine measurement of gastric residual volumes_x000D_ 2. Routine up to 6 hourly measurements of gastric residual volumes_x000D_ The allocated care pathway will be followed while routine gastric residual measurement is standard local practice_x000D_ _x000D_ OUTCOMES_x000D_ Follow-up and evaluation of outcomes will be at neonatal unit discharge or 44+0 gestational weeks+days_x000D_ _x000D_ Primary: Time from birth to reach full milk feeds for 3 consecutive days (at least 145 ml/kg/day where this is considered full enteral feeds, or where breastfeeding and any additional milk is considered equivalent to full enteral feeds)_x000D_ _x000D_ Key secondary: Necrotising enterocolitis, modified Bell’s stage 2 or greater_x000D_ _x000D_ Secondary:_x000D_ • All-cause mortality _x000D_ • Focal intestinal perforation_x000D_ • Gastrointestinal surgery_x000D_ • Late- onset infection_x000D_ • Duration of neonatal care unit stay (days)_x000D_ • Duration of any parenteral nutrition (days)_x000D_ • Length of time with a central venous line in situ (days)_x000D_ • Growth: change in weight and head circumference for gestational age standard deviation score between birth and final neonatal discharge_x000D_ • Duration of invasive ventilation (days)_x000D_ • Chronic lung disease_x000D_ • Retinopathy of Prematurity _x000D_ • Any vomiting resulting in interruption of feeds_x000D_ • Number of days feeds withheld at least once _x000D_ • Total number of hours feeds withheld_x000D_ • Breastfeeding at discharge_x000D_ • Incidence of receiving breastmilk at discharge_x000D_ _x000D_ _x000D_ HEALTH ECONOMICS: Integrated health economic analyses of resource use and costs _x000D_ _x000D_ TIMELINES FOR DELIVERY: Duration 50 months_x000D_ • 6 months set up; 36 months recruitment (12 months internal pilot & process evaluation)_x000D_ • 8 months follow up, data collection & analysis_x000D_ _x000D_ ANTICIPATED IMPACT: NeoGASTRIC will address a research priority that affects >20,000 babies in the UK and Australia annually; modest reductions in resource use will result in large clinical benefits and savings_x000D_ _x000D_ DISSEMINATION: Through journals, conferences, parent co-designed materials, social media and free online conferences for parents/patients and healthcare professionals

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH