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Standardized Application of Feeding Evaluations Using SMART Tool

NCT07136610 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2025-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Infant and Young Child Feeding

Interventions

BEHAVIORAL

SMART Tool

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ravi Mishra, MBBS, MD · Advocate Illinois Masonic Medical Center

  • Elizabeth Jensen, MPH, PhD · Wake Forest University Health Sciences

  • Joseph Chase, MPH · Advocate Aurora Research Institute

  • Anne Albi, BS, MS · Advocate Illinois Masonic Medical Center

  • Cynthia Lira-Crame, BSN, MSN · Advocate Illinois Masonic Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136610 on ClinicalTrials.gov