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NCT Number: NCT07136610

Standardized Application of Feeding Evaluations Using SMART Tool

Premature and medically complex infants have delayed development of oral feeding skills, leading to prolonged hospitalization, costs, and family stress. There is no "gold standard" infant feeding skill assessment tool for bedside clinicians. The research team developed a novel feeding skill assessment, the SMART Tool, to monitor infant feeding skill development in the neonatal intensive care unit. This study aims to determine whether this tool improves clinical outcomes, including reduced hospital days and enhanced safety and quality of infant feedings.

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Key information

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Good Shepherd Hospital, Barrington, Illinois, United States

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About this study

The current recommendation for preventing infant feeding problems is to provide cue-based feeding, which entails optimizing feeding based on infant cues, including behavioral and physiological signs of stress. These recommendations rely on appropriately recognizing infant feeding cues to inform care instead of applying time-based, volume-driven care irrespective of cues. Care providers vary widely in their subjective assessment of feeding skills, often because they lack standard education on feeding skill assessment and a "gold standard" tool to objectively measure infant oral feeding skill levels. This robust, step-wedge, cluster randomized trial was designed to evaluate the effect of implementing the SMART Tool in 14 different Neonatal Intensive Care Units (NICU) in the Advocate Health Midwest Region. The SMART Tool is a novel feeding assessment tool developed at Advocate Illinois Masonic Medical Center to objectively measure feeding readiness and skill. The psychometric properties were tested through a research study, and strong validity and reliability were established. The Advocate Health Midwest Region NICU standardization committee approved this tool as the sole feeding skill assessment tool to be used at each oral feed (eight times a day) for all NICU infants. Data on infants in the NICU will abstracted from the medical record at the time of discharge or death. The study will use PRISM and the REAIM Framework. The implementation framework consists of three parts that interact to influence outcomes (contextual factors, roll-out strategies, outcomes).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU

Exclusion criteria

  • No oral feeding started by July 15, 2026

Treatment and study plan

SMART Tool

Behavioral

The intervention in this implementation study involves (1) integrating the SMART Tool into electronic health records (EPIC), (2) educating all NICU staff (about 850 nurses, lactation consultants, speech-language pathologists, and physicians), and (3) Quality improvement to reinforce learning.

Other names: feeding skill assessment

Primary outcomes

  1. Length of hospital stay

    Time frame: Month 6

    Days from birth to discharge

  2. Number of days to full oral feeds

    Time frame: Month 6

    Days from birth to full oral feeds

  3. Percent of Nasogastric tube days

    Time frame: Month 6

    Proportion of days with NG

Secondary outcomes

  1. Home Tube Feeding

    Time frame: Month 6

    Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Liracrame, RN

CONTACT

[email protected]

773.296.7977

Ravi Mishra, MBBS,MD,FAAP

CONTACT

[email protected]

804.464.7472

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: SAFEST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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