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Standardized Application of Feeding Evaluations Using SMART Tool

Standardized Application of Feeding Evaluations Using SMART Tool

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07136610
Acronym
SAFEST
Enrollment
3500
Registered
2025-08-22
Start date
2025-08-01
Completion date
2027-07-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant and Young Child Feeding

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

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.

Detailed description

The current recommendation for preventing infant feeding problems is to provide cue-based feeding, which entails optimizing feeding based on infant cues, including behavioral and physiological signs of stress. These recommendations rely on appropriately recognizing infant feeding cues to inform care instead of applying time-based, volume-driven care irrespective of cues. Care providers vary widely in their subjective assessment of feeding skills, often because they lack standard education on feeding skill assessment and a "gold standard" tool to objectively measure infant oral feeding skill levels. This robust, step-wedge, cluster randomized trial was designed to evaluate the effect of implementing the SMART Tool in 14 different Neonatal Intensive Care Units (NICU) in the Advocate Health Midwest Region. The SMART Tool is a novel feeding assessment tool developed at Advocate Illinois Masonic Medical Center to objectively measure feeding readiness and skill. The psychometric properties were tested through a research study, and strong validity and reliability were established. The Advocate Health Midwest Region NICU standardization committee approved this tool as the sole feeding skill assessment tool to be used at each oral feed (eight times a day) for all NICU infants. Data on infants in the NICU will abstracted from the medical record at the time of discharge or death. The study will use PRISM and the REAIM Framework. The implementation framework consists of three parts that interact to influence outcomes (contextual factors, roll-out strategies, outcomes).

Interventions

BEHAVIORALSMART 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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stayMonth 6Days from birth to discharge
Number of days to full oral feedsMonth 6Days from birth to full oral feeds
Percent of Nasogastric tube daysMonth 6Proportion of days with NG

Secondary

MeasureTime frameDescription
Home Tube FeedingMonth 6Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes

Countries

United States

Contacts

CONTACTRavi Mishra, MBBS,MD,FAAP
ravi.mishra@aah.org804.464.7472
CONTACTCynthia Liracrame, RN
cynthia.liracrame@aah.org773.296.7977
STUDY_CHAIRRavi Mishra, MBBS, MD

Advocate Illinois Masonic Medical Center

PRINCIPAL_INVESTIGATORElizabeth Jensen, MPH, PhD

Wake Forest University Health Sciences

PRINCIPAL_INVESTIGATORJoseph Chase, MPH

Advocate Aurora Research Institute

PRINCIPAL_INVESTIGATORAnne Albi, BS, MS

Advocate Illinois Masonic Medical Center

PRINCIPAL_INVESTIGATORCynthia Lira-Crame, BSN, MSN

Advocate Illinois Masonic Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026