A Randomized Controlled Trial of No Routine Gastric Residual Monitoring to Guide Enteral Feeding in PICUs: Statistical Analysis Plan for the GASTRIC-PICU Trial

OBJECTIVES: To describe the prespecified statistical analysis plan for the GASTRIC-PICU, a trial to evaluate the clinical and cost-effectiveness of no routine gastric residual volume (GRV) measurement to guide enteral feeding in mechanically ventilated children admitted to a pediatric intensive care. DESIGN: Multicenter, randomised, noninferiority, open-label trial with embedded economic evaluation. SETTING: Twenty-three PICUs across England, Scotland, Northern Ireland, and Switzerland. PATIENTS: Infants and children older than 38 weeks corrected gestational age to 16 years, accepted to a participating PICU, on mechanical ventilation and being fed enterally by the gastric route. INTERVENTIONS: Standard PICU feeding protocols, but without regular GRV measurement to guide feeding. MEASUREMENTS AND MAIN RESULTS: The primary clinical outcome is an ordinal composite of survival and days free from mechanical ventilation at 30 days (noninferiority). The primary effect estimate will be the adjusted odds ratio from a proportional odds logistic regression model with two-sided 95% CI. If the lower limit is not less than 1/1.2, we will declare noninferiority. The coprimary nutritional outcome is the percentage of the child's estimated energy requirements achieved by 72 hours, which will be tested for superiority. CONCLUSIONS: The GASTRIC-PICU trial will assess the noninferiority of no routine GRV measurements compared with standard at least 6-hourly GRV measurements. Prespecified statistical and health economic analysis plans for the GASTRIC-PICU study have been developed before trial completion to minimize analytical bias.