SMART Tool for Feeding Difficulties in Premature Infants

(SAFEST Trial)

Recruiting at 13 trial locations

Overseen By Ravi Mishra, MBBS,MD,FAAP

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: No oral feeding by July 15, 2026

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the SMART Tool, designed to help doctors assess the feeding skills of premature infants in the neonatal intensive care unit (NICU). The goal is to determine if this tool can improve outcomes, such as reducing hospital stays and ensuring safer, better-quality feedings for these infants. Infants born and admitted to a NICU between August 2025 and July 2026, who have started oral feeding by mid-July 2026, may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance care for premature infants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the SMART Tool is safe for monitoring infant feeding skills?

Research shows that the SMART Tool is designed to evaluate how well premature babies can feed. It is used in the neonatal intensive care unit (NICU) to monitor their feeding skills. Unlike medications or surgeries, the SMART Tool does not enter the body, so it carries less risk.

Studies have not reported any negative effects from using the SMART Tool. Instead, they highlight its ability to accurately assess feeding skills. This suggests that the tool is likely safe for infants since it doesn't affect their physical health. The study is labeled as “Not Applicable” for phases, indicating it hasn't required the same level of testing as a new drug.

Overall, the SMART Tool helps doctors better understand and support the feeding development of premature infants without posing any direct health risks to them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART Tool because it offers a new way to assess and monitor feeding skills in premature infants, directly in the neonatal intensive care unit. Unlike current approaches that may rely on less precise observational methods, the SMART Tool systematically tracks feeding development, potentially leading to more personalized care. This tool aims to enhance understanding of an infant's feeding abilities, which could improve nutritional outcomes and support the overall growth and development of premature babies.

What evidence suggests that the SMART Tool is effective for feeding difficulties in premature infants?

Research has shown that the SMART Tool, which participants in this trial will use, could help improve feeding skills in premature babies. Studies have found that current tools for assessing feeding often lack reliability and cost-effectiveness. The SMART Tool was created to address these issues with greater accuracy and ease of use. It tracks the development of feeding skills in infants, potentially leading to shorter hospital stays and safer feeding. While specific data on its effectiveness is still being gathered, its well-thought-out design holds promise for better clinical results. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth Jensen, MPH, PhD

Principal Investigator

Wake Forest University Health Sciences

Anne Albi, BS, MS

Principal Investigator

Advocate Illinois Masonic Medical Center

Cynthia Lira-Crame, BSN, MSN

Principal Investigator

Advocate Illinois Masonic Medical Center

Joseph Chase, MPH

Principal Investigator

Advocate Aurora Research Institute

Ravi Mishra, MBBS, MD

Principal Investigator

Advocate Illinois Masonic Medical Center

Are You a Good Fit for This Trial?

This trial is for premature and medically complex infants who are developing oral feeding skills in the neonatal intensive care unit. Specific eligibility criteria have not been provided, so it's best to contact the research team for details on who can participate.

Inclusion Criteria

My baby was born between August 1, 2025, and July 31, 2026, and is in the NICU.

Exclusion Criteria

I have not started eating by mouth by July 15, 2026.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the SMART Tool to monitor infant feeding skill development in the NICU

6 months

Continuous monitoring during NICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SMART Tool

Trial Overview

The study is testing a new assessment tool called SMART Tool designed to monitor and improve infant feeding skills in premature babies. The goal is to see if using this tool can reduce hospital stays and make feedings safer and better quality.

How Is the Trial Designed?

Group I: SMART Tool Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1.

nature.com

nature.com/articles/s41598-025-21296-9

Psychometric properties of the SMART tool for infant oral ...

Available oral feeding skill assessment tools lack strong psychometrics, feasibility, and cost-effectiveness. We developed a novel tool, the ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07136610

Standardized Application of Feeding Evaluations Using ...

The research team developed a novel feeding skill assessment, the SMART Tool, to monitor infant feeding skill development in the neonatal intensive care unit.

3.

mdpi.com

mdpi.com/2227-9067/8/12/1158

Feeding Problems and Long-Term Outcomes in Preterm ...

Several bedside tools are now available for oral motor assessment of infant feeding skills. ... The Neonatal Eating Assessment Tool: Development ...

4.

researchgate.net

researchgate.net/publication/396868772_Psychometric_properties_of_the_SMART_tool_for_infant_oral_feeding_skill_assessment

(PDF) Psychometric properties of the SMART tool for infant ...

Available oral feeding skill assessment tools lack strong psychometrics, feasibility, and cost-effectiveness. We developed a novel tool, the ...

5.

pghn.org

pghn.org/DOIx.php?id=10.5223/pghn.2023.26.6.320

Developing the Mansoura Early Feeding Skills Assessment ...

... feeding assessment tool and the relationship with breast feeding self-efficacy. ... Assessment tools for evaluation of oral feeding in infants ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05729828

Psychometric Properties of the SMART Feeding Tool

This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10872325/

Transforming neonatal care with artificial intelligence

Rapid advancements in technology, data storage, and connectivity present opportunities to incorporate AI tools to create 'smart' NICUs. Table 3 summarizes ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1744165X22000257

Application and potential of artificial intelligence in ...

AI application in real-time routinely recorded neonatal intensive care vital signs. Continuous monitoring of vital signs is an essential component of ...