Title: A randomised controlled trial of no routine gastric residual monitoring to guide enteral feeding in paediatric intensive care units: the GASTRIC-PICU trial
Funder: Department of Health and Social Care

Abstract: AIM_x000D_ To find out if a common nursing practice in children's intensive care, that of measuring the child’s stomach contents frequently, compared to not doing this, impacts on the length of time the child spends on a breathing machine and their calorie intake._x000D_ _x000D_ BACKGROUND_x000D_ Nurses looking after children on intensive care units in the UK aspirate (suck out with a syringe, through a feeding tube) whatever feed or fluid is already in the stomach before they decide to give a feed or not. The idea is to ensure that the stomach is not too full of milk/feed, to prevent the child vomiting, or worse breathing milk into the lungs. However, there is virtually no research to base this practice on. In some countries (France), this practice is rarely done and appears to be safe, and recommendations in adult and preterm babies suggests stopping this practice, but no large studies have been done to examine this in children. The practice of returning the stomach contents (once it has been sucked out) may not be pleasant for the child. Furthermore, frequently aspirating and measuring the stomach contents can lead to the unnecessary stopping of the child’s feeds. This would reduce the number of calories they receive. We know from large international studies that children in intensive care already receive less than half of the calories they require. Not having enough calories (and thus energy), may affect things like the length of time they spend on breathing support and the healing of wounds. Therefore, this practice may be unnecessary and possibly harmful. If this practice is found to be unnecessary in this higher risk group of children, then this may have much broader implications and benefits for all tube fed children._x000D_ _x000D_ HOW WILL WE DO THE STUDY?_x000D_ The study is a randomised controlled trial. This means that children admitted to intensive care will be allocated by chance (‘randomisation’) to either have ‘standard care’ which is having their stomach aspirated frequently or not having their stomach aspirated to guide feeding. We will then look at the amount of time the child spends on a breathing machine, the child’s calorie intake, the risk of breathing milk into the lungs, and the likelihood of picking up a severe bowel infection in babies._x000D_ _x000D_ INVOLVING PATIENTS AND PARENTS_x000D_ This planned research has been shaped by our recently completed smaller study (called a feasibility study) to find out parent’s (and intensive care staffs’) views around a future study. Overall, families were supportive of a trial and helped us to develop parent information leaflets and determine when families should be approached. Parents and families are also involved in this planned study. They are helping us design this study, so it is as sensitive and acceptable as possible. _x000D_ _x000D_ WHO WILL HEAR ABOUT THE RESULTS?_x000D_ We will present our study findings at national and international meetings as well as publishing the findings in widely read medical journals. We will also involve our parent and family representatives to communicate the results of the study in an easily understandable way and communicate this via our national professional and other relevant societies and via social media and parent support groups and charities.

Lay abstract: AIM: To determine the clinical and cost-effectiveness of not performing routine gastric residual volume measurement to guide enteral feeding and to determine if it is non-inferior to standard care of gastric residual volume measurement in mechanically ventilated children admitted to paediatric intensive care. _x000D_ _x000D_ The Research Question is: In mechanically ventilated children (Population), is no routine measurement of gastric residual volume (Intervention) non-inferior to regular up to 6 hourly gastric residual volume measurement (Control) in terms (Outcome) of survival and days free from mechanical ventilation (non-inferiority) and superior for energy target achievement (superiority) _x000D_ _x000D_ DESIGN: Multi-centre, randomised, noninferiority, open-label trial with inbuilt pilot phase, health economic evaluation and patient follow up 6 months._x000D_ _x000D_ SETTING: 19 United Kingdom Paediatric Intensive Care Units (PICU) _x000D_ _x000D_ POPULATION: 4700 children (>=37 weeks age to <17 years of age) admitted to a UK PICU who are invasively ventilated during PICU admission (and expected to stay ventilated more than 48 hours) who can be fed via gastric route. _x000D_ _x000D_ INTERVENTION: No routine gastric residual volume measurement to guide enteral feeding _x000D_ COMPARATOR: Regular at least 6 hourly gastric residual volume measurement_x000D_ _x000D_ USUAL CARE: Standard unit feeding protocols will be followed (in both arms) but the usual care will have enteral feeds guided by regular up to 6 hourly GRV measurements with thresholds to withhold feeds set at >5mlk/kg or >250 mls in children larger than 40Kg. _x000D_ _x000D_ OUTCOME MEASURES: The co-primary outcomes are A) non-inferiority of a composite of survival and days free from mechanical ventilation within 30 days and B) superiority of achievement of the child’s predicted energy requirements by 72 hours after PICU admission. _x000D_ _x000D_ Secondary outcomes: Time to achievement of full (target) feeds, Time to achieve target protein requirements, Diagnosis of Ventilator Associated Pneumonia, diagnosis of necrotising enterocolitis in infants, duration of time with no enteral feed in 24-hour period, incidence of vomiting, feed intolerance, healthcare acquired infections, compliance, length of PICU stay, change in weight, length of hospital stay, Pediatric Quality of Life, Functional Status Score, shortened age-appropriate feeding questionnaire, weight and height and Z score._x000D_ _x000D_ SAMPLE SIZE: 4700 children (2350 per arm) will provide 90% power to confirm the absence of a difference of 12 hours of greater in median ventilation duration (non-inferiority margin) with no change in mortality, allowing for 5% withdrawal and 10% crossover and allowing for a per protocol analysis. _x000D_ _x000D_ PROJECT TIMETABLE: Target randomisation rate 10 patients/centre/month across 19 UK sites. Study duration 42 months: 6 months set up, 26 months recruitment (10 months pilot and 16 months main trial), 6 months follow up; 4 months analysis and report. _x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION: If not routinely measuring GRV is shown to be non-inferior, we will work closely with stakeholders to impact clinical guidance and incorporate this into routine practice. If it is shown not to be non-inferior, then practice would not need to be changed. Results will be rapidly disseminated to all stakeholders through a variety of media, publication in peer-reviewed journals, presentations and via social media

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: GENERIC HEALTH RELEVANCE