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

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Authors

  • Parag dekate
     Dept of Paediatric, Krishna institute if medical Science, Hyderabad ,IN
  • Avinash Reddy
     Dept of Paediatric, Krishna institute if medical Science, Hyderabad ,IN

DOI:

https://doi.org/10.21048/IJND.2024.61.1.35015

Keywords:

Groviva® Advance, enteral tube feed, isocaloric formula, paediatric, critically ill, intensive care unit.

Abstract

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. This was a prospective five-day single centre, open label clinical study. 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 [1 kcal in 1 ml]) and dosed three hourly (or at the discretion of the pediatrician). 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. Groviva® Advance was found to be safe and well tolerated by critically ill children admitted to PICUs.

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Published

2024-03-01

How to Cite

dekate, P., & Reddy, A. (2024). 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. The Indian Journal of Nutrition and Dietetics, 61(1), 73–83. https://doi.org/10.21048/IJND.2024.61.1.35015

Issue

Volume 61, Issue 1, January-March 2024

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Articles

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Copyright (c) 2024 Parag dekate, Avinash Reddy

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Europe PMC
Received 2023-09-12
Accepted 2024-03-05
Published 2024-03-01

 

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