ActivePregnancy, Children & Inherited ConditionsDigestion, Kidneys & Other Organs
A randomised controlled trial of no routine gastric residual monitoring to guide enteral feeding in paediatric intensive care units: the GASTRIC-PICU trial
Recipient organisationIntensive Care National Audit and Research Centre (icnarc)
Funding£2.0M
PeriodSept 2022 — Sept 2026
In plain English
AI plain-English summary
Every day in paediatric intensive care units across the UK, nurses stop feeding a ventilated child because a stomach tube shows leftover milk—and no one knows whether that precaution helps or harms. This trial will test whether scrapping routine checks of gastric residual volume (GRV) in 4,700 mechanically ventilated children leads to outcomes no worse than current practice, while also helping children meet their energy needs faster. The problem is that measuring GRV is standard care, but the evidence behind it is thin. The measurement often triggers feed interruptions, which can leave critically ill children undernourished at a time when they need energy most. If the trial shows that skipping routine GRV checks is safe and improves calorie delivery, it could change feeding protocols across the NHS, reducing unnecessary interruptions and potentially shortening time on a ventilator. The trial will run across 19 UK paediatric intensive care units over 42 months, with a 6-month follow-up on quality of life and functional status. If the intervention proves non-inferior, the team will work with stakeholders to update clinical guidance. If it does not, practice remains unchanged—but the question will have been answered with robust data.
View original technical description
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. 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) DESIGN: Multi-centre, randomised, noninferiority, open-label trial with inbuilt pilot phase, health economic evaluation and patient follow up 6 months. SETTING: 19 United Kingdom Paediatric Intensive Care Units (PICU) 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. INTERVENTION: No routine gastric residual volume measurement to guide enteral feeding COMPARATOR: Regular at least 6 hourly gastric residual volume measurement 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. 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. 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. 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. 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. 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
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