Recruiting

SMART ToolStandardized Application of Feeding Evaluations Using SMART Tool

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07136610

Conditions

Infant and Young Child Feeding

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

SMART Tool

Study Details

Brief 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

Study ID

NCT07136610

Start date

Aug 1, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: SMART Tool

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

Interventions

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.

Primary outcome measure

Length of hospital stay [ Time Frame: Month 6 ]
Number of days to full oral feeds [ Time Frame: Month 6 ]
Percent of Nasogastric tube days [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Ravi Mishra, MBBS,MD,FAAP

804.464.7472 ravi.mishra@aah.org

Cynthia Liracrame, RN

773.296.7977 cynthia.liracrame@aah.org

Locations

Advocate Good Shepherd Hospital

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Hope Reis, NPD

804-464-7472 hope.reis@aah.org

Advocate Trinity Hospital

Recruiting

Chicago, Illinois, United States, 60617

Contacts

Karen Beagles, RN

804-464-7472 karen.beagles@aah.org

Advocate Sherman Hospital

Recruiting

Elgin, Illinois, United States, 60123

Contacts

Cynthia Manly, RN

804-464-7472 cynthia.manly@aah.org

Advocate Condell Medical Center

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Heidi Gutwoski, NPD

804-464-7472 heidi.gutowski@aah.org

Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Edythe Oliver, NPD

804-464-7472 edythe.oliver@aah.org

Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Katie Kurnick, NPD

804-464-7472 katie.kurncik@aah.org

Aurora Medical Center Grafton

Recruiting

Grafton, Wisconsin, United States, 53024

Contacts

Julie Bulgrin, NPD

804-464-7472 julie.bulgrin@aah.org

Aurora BayCare Medical Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Erica Huettl, NPD

804-464-7472 erica.huettl@aah.org

Aurora Medical Center Kenosha

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

Margaret Loehrke, NPD

804-464-7472 margaret.loehrke@aah.org

Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Kate Scythe, NPD

804-464-7472 katelyn.scythe@aah.org

Aurora Medical Center Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Abbey Schonscheck, RN

804-464-7472 abbey.schonscheck@aah.org

Aurora Medical Center - Sheboygan County

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Michaele Schramm, RN

804-464-7472 michaele.schramm@aah.org

Aurora Medical Center - Summit

Recruiting

Summit, Wisconsin, United States, 53066

Contacts

Dawn Hron, NPD

804-464-7472 dawn.hron@aah.org

Aurora West Allis Medical Center

Recruiting

West Allis, Wisconsin, United States, 53227

Contacts

Shannon Schubel, NPD

804-464-7472 shannon.schubel@aah.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

premature infants
medically complex infants
infant feeding
feeding skills assessment
length of stay
infant developmental assessment
dysphagia of newborn
cluster randomized trial
length of NICU stay
breastfeeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-29.