Standardized bedside feeding checks using the SMART Tool
Official title: Standardized Application of Feeding Evaluations Using SMART Tool
Run by Wake Forest University Health Sciences · NCT07136610 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 14 sites (Barrington, Illinois and 13 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07136610 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 8 more locations
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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
- Email: ravi.mishra@aah.org
- Phone: 804.464.7472
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.