Evaluating the SMART Tool for Infant Feeding in the NICU
This study is looking at a new way to help premature and medically complex infants learn to feed by mouth. It's testing a tool called the SMART Tool, which helps nurses and doctors objectively measure an infant's feeding skills. The goal is to see if using the SMART Tool can help babies leave the hospital sooner, reduce the number of days they need a feeding tube (Nasogastric tube), and help them start eating by mouth more quickly. This study will involve about 3500 infants who are admitted to the Neonatal Intensive Care Unit (NICU) between August 1, 2025, and July 31, 2026. The study is looking for infants from birth up to 1 year old.
- Study design
- This is an interventional study that will involve 3500 infants across 14 different Neonatal Intensive Care Units (NICU). It is a robust, step-wedge, cluster randomized trial.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure outcomes like length of hospital stay, days to full oral feeds, and percent of Nasogastric tube days at Month 6.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Standardized Application of Feeding Evaluations Using SMART Tool
At a glance
Conditions
NCT07136610
Where you'd take part
This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)
Oak Lawn, Illinoisstudy coordinator listed
Recruiting
Advocate Condell Medical Center
Libertyville, Illinoisstudy coordinator listed
Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinoisstudy coordinator listed
Recruiting
Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)
Park Ridge, Illinoisstudy coordinator listed
Recruiting
Advocate Sherman Hospital
Elgin, Illinoisstudy coordinator listed
Recruiting
Advocate Trinity Hospital
Chicago, Illinoisstudy coordinator listed
Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsinstudy coordinator listed
Recruiting
Aurora Medical Center - Sheboygan County
Sheboygan, Wisconsinstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ravi Mishra, MBBS, MD · STUDY_CHAIR · Advocate Illinois Masonic Medical Center
- Elizabeth Jensen, MPH, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
- Joseph Chase, MPH · PRINCIPAL_INVESTIGATOR · Advocate Aurora Research Institute
- Anne Albi, BS, MS · PRINCIPAL_INVESTIGATOR · Advocate Illinois Masonic Medical Center
- Cynthia Lira-Crame, BSN, MSN · PRINCIPAL_INVESTIGATOR · Advocate Illinois Masonic Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Length of hospital stayMonth 6
Days from birth to discharge
- Number of days to full oral feedsMonth 6
Days from birth to full oral feeds
- Percent of Nasogastric tube daysMonth 6
Proportion of days with NG