Standardized Application of Feeding Evaluations Using SMART Tool

Part of paid clinical trials in Barrington, Illinois.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07136610
Status
Recruiting

Conditions

  • Infant and Young Child Feeding

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
3,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SMART Tool
    Feeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit.

Primary Outcome Measure

Length of hospital stay [ Time Frame: Month 6 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Advocate Good Shepherd HospitalBarringtonIllinois60010
Hope Reis, NPD
804-464-7472
Jenna Felix, RN (SUB_INVESTIGATOR)
Myriam Hernandez, RN (SUB_INVESTIGATOR)
Advocate Trinity HospitalChicagoIllinois60617
Karen Beagles, RN
804-464-7472
Amber Barnes, RN (SUB_INVESTIGATOR)
Advocate Sherman HospitalElginIllinois60123
Cynthia Manly, RN
804-464-7472
Julie Vannoord
Cynthia Manly, RN (SUB_INVESTIGATOR)
Advocate Condell Medical CenterLibertyvilleIllinois60048
Heidi Gutwoski, NPD
804-464-7472
Heidi Gutwoski, NPD (SUB_INVESTIGATOR)
Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)Oak LawnIllinois60453
Edythe Oliver, NPD
804-464-7472
Katlynn Alanza, RN (SUB_INVESTIGATOR)
Kimberly Butny, NPD (SUB_INVESTIGATOR)
Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)Park RidgeIllinois60068
Katie Kurnick, NPD
804-464-7472
Angela Lake, RN (SUB_INVESTIGATOR)
Margaret Behm, NPD (SUB_INVESTIGATOR)
Aurora Medical Center GraftonGraftonWisconsin53024
Julie Bulgrin, NPD
804-464-7472
Julie Bulgrin, NPD (SUB_INVESTIGATOR)
Amy Gundrum, RN (SUB_INVESTIGATOR)
Aurora BayCare Medical CenterGreen BayWisconsin54311
Erica Huettl, NPD
804-464-7472
Halli Schneiderwendt, RN (SUB_INVESTIGATOR)
Aurora Medical Center KenoshaKenoshaWisconsin53142
Margaret Loehrke, NPD
804-464-7472
Samantha Goodenough, RN (SUB_INVESTIGATOR)
Aurora Sinai Medical CenterMilwaukeeWisconsin53233
Kate Scythe, NPD
804-464-7472
Shannon Brandel, SLP (SUB_INVESTIGATOR)
Aurora Medical Center OshkoshOshkoshWisconsin54904
Abbey Schonscheck, RN
804-464-7472
Wendy Roesler, RN (SUB_INVESTIGATOR)
Aurora Medical Center - Sheboygan CountySheboyganWisconsin53081
Michaele Schramm, RN
804-464-7472
Sara Jeanty, NPD
Michaele Schramm, RN (SUB_INVESTIGATOR)
Aurora Medical Center - SummitSummitWisconsin53066
Dawn Hron, NPD
804-464-7472
Dawn Hron, NPD (SUB_INVESTIGATOR)
Brenda Hahn, RN (SUB_INVESTIGATOR)
Aurora West Allis Medical CenterWest AllisWisconsin53227
Shannon Schubel, NPD
804-464-7472
Carlye Butler, RN (SUB_INVESTIGATOR)
Jennifer Kurziak, RN (SUB_INVESTIGATOR)

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