Standardized Application of Feeding Evaluations Using SMART Tool
- Conditions
- Infant and Young Child Feeding
- Registration Number
- NCT07136610
- Lead Sponsor
- Wake Forest University Health Sciences
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3500
- Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU
- No oral feeding started by July 15, 2026
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Length of hospital stay Month 6 Days from birth to discharge
Number of days to full oral feeds Month 6 Days from birth to full oral feeds
Percent of Nasogastric tube days Month 6 Proportion of days with NG
- Secondary Outcome Measures
Name Time Method Home Tube Feeding Month 6 Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes
Trial Locations
- Locations (14)
Advocate Good Shepherd Hospital
🇺🇸Barrington, Illinois, United States
Advocate Trinity Hospital
🇺🇸Chicago, Illinois, United States
Advocate Sherman Hospital
🇺🇸Elgin, Illinois, United States
Advocate Condell Medical Center
🇺🇸Libertyville, Illinois, United States
Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)
🇺🇸Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)
🇺🇸Park Ridge, Illinois, United States
Aurora Medical Center Grafton
🇺🇸Grafton, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Aurora Medical Center Kenosha
🇺🇸Kenosha, Wisconsin, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Scroll for more (4 remaining)Advocate Good Shepherd Hospital🇺🇸Barrington, Illinois, United StatesHope Reis, NPDContact804-464-7472hope.reis@aah.orgJenna Felix, RNSub InvestigatorMyriam Hernandez, RNSub Investigator