The neoGASTRIC trial: Avoiding routine gastric residual volume measurement in neonatal critical care, a multi-centre, randomised controlled trial

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)? 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. 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 METHODS: An individually randomised, controlled, unblinded, trial comparing two parallel care pathways, with an internal pilot and process evaluation POPULATION: Preterm infants admitted to participating UK or Australian neonatal units ELIGIBILITY Inclusion criteria: Preterm birth ≪34+0 gestational weeks+days; within 24 hours of starting feeds (receiving ≫15 ml/kg/day) Exclusion criteria: Nasogastric tube or orogastric not required; gastrointestinal surgical condition; major congenital abnormality CARE PATHWAYS TO BE COMPARED 1. No routine measurement of gastric residual volumes 2. Routine up to 6 hourly measurements of gastric residual volumes The allocated care pathway will be followed while routine gastric residual measurement is standard local practice OUTCOMES Follow-up and evaluation of outcomes will be at neonatal unit discharge or 44+0 gestational weeks+days 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) Key secondary: Necrotising enterocolitis, modified Bell's stage 2 or greater Secondary: All-cause mortality Focal intestinal perforation Gastrointestinal surgery Late- onset infection Duration of neonatal care unit stay (days) Duration of any parenteral nutrition (days) Length of time with a central venous line in situ (days) Growth: change in weight and head circumference for gestational age standard deviation score between birth and final neonatal discharge Duration of invasive ventilation (days) Chronic lung disease Retinopathy of Prematurity Any vomiting resulting in interruption of feeds Number of days feeds withheld at least once Total number of hours feeds withheld Breastfeeding at discharge Incidence of receiving breastmilk at discharge HEALTH ECONOMICS: Integrated health economic analyses of resource use and costs TIMELINES FOR DELIVERY: Duration 50 months 6 months set up; 36 months recruitment (12 months internal pilot & process evaluation) 8 months follow up, data collection & analysis 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 DISSEMINATION: Through journals, conferences, parent co-designed materials, social media and free online conferences for parents/patients and healthcare professionals