Protocol for a Randomized Clinical Trial to Evaluate Not Routinely Measuring Gastric Residual Volume to Guide Enteral...

Area of Science:

• Pediatric Intensive Care Medicine
• Clinical Nutrition
• Health Economics

Background:

• Enteral nutrition is crucial for critically ill children, but routine gastric residual volume (GRV) measurement frequently interrupts feeding.
• High GRV measurements often lead to unnecessary feed cessation, potentially compromising nutritional intake.

Purpose of the Study:

• To assess the clinical and cost-effectiveness of discontinuing routine GRV measurements in mechanically ventilated children receiving enteral feeds.
• To compare standard feeding protocols without routine GRV measurement against protocols with routine (≥6-hourly) GRV measurement.

Main Methods:

• A multicenter, randomized, non-inferiority, open-label clinical trial (GASTRIC-PICU) involving 23 PICUs in the UK and Switzerland.
• Participants include ventilated infants and children (≥37 weeks corrected gestational age to 16 years) receiving enteral feeds.
• The primary clinical outcome is a composite of survival and days free from mechanical ventilation at 30 days; a co-primary outcome is energy requirements achieved by 72 hours. Health economic evaluation is embedded.

Main Results:

• The study compares standard feeding without routine GRV measurement against standard feeding with routine GRV measurement.
• Data collected include baseline demographics, clinical status, daily nutritional intake, and 30-day and 6-month outcomes (clinical and economic).
• The primary clinical outcome is assessed for non-inferiority, with a co-primary outcome for nutritional delivery superiority.

Conclusions:

• The GASTRIC-PICU trial will determine if withholding routine GRV measurements is clinically effective and cost-effective.
• Findings will inform best practices for enteral feeding management in pediatric intensive care.
• Results will be disseminated through peer-reviewed publications, conferences, and social media.