Protocol for a Randomized Clinical Trial to Evaluate Not Routinely Measuring Gastric Residual Volume to Guide Enteral Feeding Versus Routine Measurement in Mechanically Ventilated Critically Ill Children (GASTRIC-PICU)

Objective: Providing adequate nutrition is a key aspect of pediatric intensive care, with enteral administration preferred. The regular measurement of gastric residual volume (GRV) to guide feeding is common, but it results in frequent feed interruptions due to a perceived high GRV. The GASTRIC-PICU (GRV to guide enteral feeding vs. routine measurement in mechanically ventilated critically ill children) randomized controlled trial aims to evaluate the clinical and cost-effectiveness of not routinely measuring GRV to guide enteral feeding compared with the usual practice of routine measurement. Design: Multicenter, randomized, non-inferiority, open-label clinical trial with embedded health economic evaluation. Setting: Twenty-three PICUs across United Kingdom, Scotland, Northern Ireland, and Switzerland. Patients: Infants and children 37 weeks old or older corrected gestational age to 16 years admitted to participating PICUs, on mechanical ventilation and being enterally fed. Intervention and Comparison: Standard feeding protocols without routinely measuring GRV to guide feeding will be compared against standard feeding protocols with routine (at least 6-hourly) GRV measurement to guide feeding. Measurements and Main Results: Randomization 1:1 between no routine GRV measurement and routine GRV measurement stratified by site, age at admission, and main reason for admission. “Research Without Prior Consent” will be used. The primary clinical outcome is a composite outcome of survival and days free from mechanical ventilation at 30 days (non-inferiority). The superiority co-primary outcome is the percentage of the child’s estimated energy requirements achieved by 72 hours after randomization. The primary outcome of cost-effectiveness analysis is incremental net monetary benefits at 6 months. Baseline demographics and clinical status, daily nutritional data for the first 7 days, and discharge outcome, as well as longer-term survival and economic data will be collected. Conclusions: Trial findings will be disseminated in peer reviewed journals, via international conferences and in lay language via social media.