SMART Tool for Feeding Difficulty

(RIOS Trial)

Overseen By Cynthia Lira-Crame, MSN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Infant deaths, Transfers, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well infants can feed independently by the time they leave the neonatal intensive care unit (NICU). Researchers seek to determine if babies who can drink a full feed by bottle or breast have fully developed feeding skills. The trial focuses on infants admitted to and discharged from the Advocate Illinois Masonic Medical Center NICU between April and September 2024. Babies who were in this NICU during this period and can feed independently might be suitable for the study.

As an unphased study, this trial offers a unique opportunity to contribute to understanding infant feeding development, potentially benefiting future NICU graduates.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SMART Tool for Feeding Skill Assessment is safe for infants?

Research has shown that the SMART Tool for Feeding Skill Assessment evaluates how well infants feed in the neonatal intensive care unit (NICU). Studies examining its reliability have not identified any safety problems or negative effects. This indicates that the tool is safe and comfortable for infants during feeding skill assessments. As the SMART Tool is solely for assessment and not treatment, it remains non-invasive and poses minimal risk to infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance our understanding of how infants in the NICU develop oral feeding skills. Unlike standard practices that primarily focus on nutritional support through feeding tubes or bottles, this trial seeks to identify key factors and methods that can improve oral feeding readiness and skill acquisition in premature or medically fragile infants. By gaining insights into these developmental processes, the trial could lead to more personalized and effective feeding strategies, potentially reducing hospital stays and promoting better growth and development outcomes for these infants.

What evidence suggests that the SMART Tool for Feeding Skill Assessment is effective for evaluating infant feeding skills?

Research shows that the SMART Tool assesses how well infants in the neonatal intensive care unit (NICU) can feed orally. Studies have found that the SMART Tool is fairly accurate, with a sensitivity of 0.76 and a specificity of 0.82. This means it reliably identifies different levels of feeding skills. The tool categorizes feeding skills into three groups: caution, developing, and capable, helping caregivers understand an infant's feeding progress and needs. Overall, the SMART Tool provides a dependable way to evaluate and monitor the development of feeding skills in infants. ^{1 6 7 8 9}

Who Is on the Research Team?

Ravi Mishra, MD, FAAP

Principal Investigator

Advocate Health

Are You a Good Fit for This Trial?

Inclusion Criteria

My newborn was in AIMMC's NICU between April and September 2024.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Infants' feeding skills are assessed using the SMART Tool to determine their skill level at discharge

Up to 6 months

Ongoing assessments during NICU stay

Follow-up

Participants are monitored for feeding skill development and potential pediatric feeding disorders after discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SMART Tool for Feeding Skill Assessment

How Is the Trial Designed?

Group I: NICU Infants Experimental Treatment 1 Intervention

One cohort of infants who were admitted and discharged during the study period.

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 ...

The purpose of the SMART tool is to measure oral feeding skills in infants in the NICU. This study assessed its psychometric properties compared ...

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41136627/

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

Compared to NEOA, the SMART tool had a sensitivity of 0.76 (95% CI 0.63-0.89) and a specificity of 0.82 (95% CI 0.72-0.93), with a strong ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/a87cb496b5f896e8/nct06736743-infant-oral-feeding-skills-review

Review of Infant Oral Feeding and Skills | MedPath

The post-feed SMART Tool score classifies the infant feeding skills into three categories: caution (25 to 60), developing (60 to 90), and capable (91 to 100).

5.

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 ...

Compared to NEOA, the SMART tool had a sensitivity of 0.76 (95% CI 0.63–0.89) and a specificity of 0.82 (95% CI 0.72–0.93), with a strong ...

6.

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.

7.

trial.medpath.com

trial.medpath.com/clinical-trial/c556454582dd72bc/nct07136610-standardized-feeding-evaluations-smart-tool

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.

8.

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.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2828611/

The Early Feeding Skills Assessment for Preterm Infants - PMC

This article describes the Early Feeding Skills (EFS) Assessment, a checklist designed to standardize the measurement of feeding skills of preterm infants and ...