An open-label clinical study to evaluate the safety and gastrointestinal tolerance (product compliance) of Groviva®® Advance in hospitalized children requiring isocaloric formula for enteral tube feeding
Main Article Content
Abstract
Objective: The aim of this study is to evaluate the safety and gastrointestinal tolerance of Groviva® Advance in pediatric patients hospitalized to pediatric intensive care units (PICUs) and requiring an isocaloric formula for enteral tube feeding.
Design: This was a prospective five-day single centre, open label clinical study.
Methods: The safety and tolerance of Groviva® Advance (45 gram in 170 millilitres of water) was evaluated every day from Day 1 to the end of hospitalization or Day 5, whichever was earlier. The reconstituted amount was 210 millilitres (equivalent to 200 kcal [1kcal in 1ml]) and dosed three hourly (or at the discretion of the pediatrician).
Results: The majority of participants received the Groviva® Advance tube feed three hourly on all five days of the study. The average range of total feeds varied from 295.16 ± 275.19 to 1074.737 ± 347.94 feeds per day. The most common side effects were loose stools or vomiting; if present, majority of participants had only one episode per day. There was minimal or no total daily aspiration or GRV (>500 ml/day). There was no statistically significant change in weight (P=0.7163) and abdominal girth (0.6381) of study participants. There were no issues encountered during the preparation and administration of Groviva® Advance.
Conclusion: Groviva® Advance was found to be safe and well tolerated by critically ill children admitted to PICUs.
Article Details
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