Standardized Application of Feeding Evaluations Using SMART Tool

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU

Disqualifiers

No oral feeding started by July 15, 2026

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

3,500 Participants
are divided into 1 treatment group
Group A: SMART ToolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay

Days from birth to discharge

Time frame
Month 6
2

Number of days to full oral feeds

Days from birth to full oral feeds

Time frame
Month 6
3

Percent of Nasogastric tube days

Proportion of days with NG

Time frame
Month 6

Secondary outcomes

1

Home Tube Feeding

Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes

Time frame
Month 6

Other outcomes

Sponsors and contacts

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