SMART Tool for Feeding Difficulties in Premature Infants

(SAFEST Trial)

This trial tests a new tool called the SMART Tool, designed to help doctors assess the feeding skills of premature infants in the neonatal intensive care unit (NICU). The goal is to determine if this tool can improve outcomes, such as reducing hospital stays and ensuring safer, better-quality feedings for these infants. Infants born and admitted to a NICU between August 2025 and July 2026, who have started oral feeding by mid-July 2026, may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance care for premature infants.

The trial information does not specify whether participants need to stop taking their current medications.

Research shows that the SMART Tool is designed to evaluate how well premature babies can feed. It is used in the neonatal intensive care unit (NICU) to monitor their feeding skills. Unlike medications or surgeries, the SMART Tool does not enter the body, so it carries less risk.

Studies have not reported any negative effects from using the SMART Tool. Instead, they highlight its ability to accurately assess feeding skills. This suggests that the tool is likely safe for infants since it doesn't affect their physical health. The study is labeled as “Not Applicable” for phases, indicating it hasn't required the same level of testing as a new drug.

Researchers are excited about the SMART Tool because it offers a new way to assess and monitor feeding skills in premature infants, directly in the neonatal intensive care unit. Unlike current approaches that may rely on less precise observational methods, the SMART Tool systematically tracks feeding development, potentially leading to more personalized care. This tool aims to enhance understanding of an infant's feeding abilities, which could improve nutritional outcomes and support the overall growth and development of premature babies.

Research has shown that the SMART Tool, which participants in this trial will use, could help improve feeding skills in premature babies. Studies have found that current tools for assessing feeding often lack reliability and cost-effectiveness. The SMART Tool was created to address these issues with greater accuracy and ease of use. It tracks the development of feeding skills in infants, potentially leading to shorter hospital stays and safer feeding. While specific data on its effectiveness is still being gathered, its well-thought-out design holds promise for better clinical results.¹²⁶⁷⁸