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

Paloma Ferrando-Vivas; Julia M. Broomhall; Zia Sadique; Paul Mouncey; David A Harrison; Mark J. Peters; Lyvonne N. Tume; on behalf of the GASTRIC-PICU Trial Investigators

doi:10.1097/pcc.0000000000004008

July 1, 2026Pediatric Critical Care Medicine

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

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Key Points

The aim is to evaluate the clinical and cost-effectiveness of no routine measurement of gastric residual volume in guiding enteral feeding for mechanically ventilated children.
Multicenter, randomized, noninferiority, open-label trial across 23 PICUs in England, Scotland, Northern Ireland, and Switzerland.
Participants include infants and children on mechanical ventilation, excluding routine gastric residual volume measurements.
Primary outcome measured is an ordinal composite of survival and days free from mechanical ventilation at 30 days.
The primary effect estimate will be determined through adjusted odds ratios from a proportional odds logistic regression model with 95% CI.
Noninferiority will be declared if the lower limit of the confidence interval is not less than 1/1.2.
The coprimary nutritional outcome will test for superiority regarding the percentage of energy requirements achieved by 72 hours.

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Implication

Randomized trial assesses noninferiority of no routine gastric residual volume measurement in mechanically ventilated children, suggesting updated feeding protocols.

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Ferrando-Vivas et al. (2026) studied this question.

synapsesocial.com/papers/6a4754f05c29257aa257a46e https://doi.org/10.1097/pcc.0000000000004008

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

Key Points

No abstract yet

Implication

Discussion

Cite This Study

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

Key Points

No abstract yet

Implication

Discussion

Cite This Study

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