Clinical trial Recruiting at 14 sites Interventional Ages Any age to 1 Year

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 typeInterventional
AgesAny age to 1 Year
SexAll
Enrollment3500 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations14 sites (Barrington, Illinois and 13 other locations)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedJuly 2027
Study endsJuly 2027
Registry record updatedJuly 29, 2026
Trial IDNCT07136610 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.