Standardized bedside feeding checks using the SMART Tool

Standardized Application of Feeding Evaluations Using SMART Tool

This project will test whether using the SMART Tool for premature and medically complex infants in the NICU improves feeding safety and shortens hospital stays.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3500 (estimated)
• Ages: N/A to 1 Year
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Locations: 14 sites (Barrington, Illinois and 13 other locations)
• Trial ID: NCT07136610 on ClinicalTrials.gov

What this trial studies

This is a stepped-wedge, cluster randomized implementation across multiple NICUs in the Advocate Health Midwest Region where the SMART Tool replaces usual bedside feeding assessments. The SMART Tool is applied at every oral feed (up to eight times daily) and staff receive standardized training before each unit transitions to the tool. Researchers will compare clinical outcomes such as length of stay, feeding safety, and feeding quality using medical record data abstracted at discharge or death. Implementation and impact will be analyzed using the PRISM and RE-AIM frameworks.

Who should consider this trial

Good fit: Premature or medically complex infants born between August 1, 2025 and July 31, 2026 who are admitted to a participating NICU and begin oral feeding before July 15, 2026.

Not a fit: Infants who never start oral feeds by July 15, 2026, those not admitted to a participating NICU, or infants with conditions that preclude oral feeding are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the SMART Tool could shorten NICU stays and improve the safety and quality of oral feedings for premature and medically complex infants.

How similar studies have performed: Preliminary psychometric testing of the SMART Tool showed strong validity and reliability, but large-scale, multi-unit implementation effects on clinical outcomes are still novel and being tested.

Eligibility criteria

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

Where this trial is running

Barrington, Illinois and 13 other locations

• Advocate Good Shepherd Hospital — Barrington, Illinois, United States (RECRUITING)
• Advocate Trinity Hospital — Chicago, Illinois, United States (RECRUITING)
• Advocate Sherman Hospital — Elgin, Illinois, United States (RECRUITING)
• Advocate Condell Medical Center — Libertyville, Illinois, United States (RECRUITING)
• Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn) — Oak Lawn, Illinois, United States (RECRUITING)
• Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge) — Park Ridge, Illinois, United States (RECRUITING)
• Aurora Medical Center Grafton — Grafton, Wisconsin, United States (RECRUITING)
• Aurora BayCare Medical Center — Green Bay, Wisconsin, United States (RECRUITING)
• Aurora Medical Center Kenosha — Kenosha, Wisconsin, United States (RECRUITING)
• Aurora Sinai Medical Center — Milwaukee, Wisconsin, United States (RECRUITING)
• Aurora Medical Center Oshkosh — Oshkosh, Wisconsin, United States (RECRUITING)
• Aurora Medical Center - Sheboygan County — Sheboygan, Wisconsin, United States (RECRUITING)
• Aurora Medical Center - Summit — Summit, Wisconsin, United States (RECRUITING)
• Aurora West Allis Medical Center — West Allis, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Elizabeth Jensen, MPH, PhD — Wake Forest University Health Sciences
• Study coordinator: Ravi Mishra, MBBS,MD,FAAP

Conditions: Infant and Young Child Feeding, premature infants, medically complex infants, infant feeding, feeding skills assessment, length of stay, infant developmental assessment, dysphagia of newborn