Review of Infant Oral Feeding and Skills (RIOS)

February 20, 2026 updated by: Wake Forest University Health Sciences

Review of Infant Oral Feeding and Skills Study

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Situation: Feeding Problems in Infancy

Feeding problems are a frequent complication for infants in the neonatal intensive care unit (NICU), with an estimated 80% of infants experiencing feeding difficulties during their NICU stay. Inadequate oral feeding (by volume) is one of the most common reasons for prolonged NICU stays. Feeding problems are common reasons for hospital readmission in the moderate and late preterm population. In a large multicenter retrospective study of premature infants born before 33 weeks gestation, less than 4% were discharged from NICU with feeding tubes (nasogastric or gastrostomy) for severe feeding problems. However, in the pediatric setting, a meta-analysis found that 42% of premature infants born before 37 weeks had ongoing feeding problems before four years of age. The 10x difference in the prevalence of feeding problems in NICU and pediatric settings implies that infants either have inadequate feeding skills at discharge or develop them later at home. The disparity in the literature begs the question of whether clinicians are adequately assessing feeding skill development in the NICU setting.

In severe cases, feeding problems in childhood cause immense stress to the child and family at mealtime. Pediatric Feeding Disorder (PFD) is defined as impaired oral intake that is not age-appropriate and is associated with medical, nutritional, feeding skills, and/or psychosocial dysfunction. While a skill-based approach to treating PFD is essential in the pediatric world, skill-based information is not fully appreciated in the NICU.

Background: Skill Based Feeding

Feeding management is central to the baby's physiological balance, growth, behavioral display of pleasure, and a nurturing relationship with the parent. The acquisition of safe and efficient nipple-feeding skills is a complex task and one of the most challenging milestones for most preterm or high-risk infants to achieve. Premature infants are at higher risk of feeding problems compared to term infants due to 1. Innate differences in muscle tone, state regulation, endurance, and suck-swallow-breathing coordination; 2. Disruption of in utero brain development due to decreased myelination and white matter disturbances, and 3. They have higher nutritional requirements per kilogram body weight than term infants and are less tolerant of high fluid volumes. Similarly, full-term infants with complex conditions and syndromes may have altered anatomy, physiology and neurodevelopment, which impact oral feeding.

Cue-based feeding (CBF) is considered best practice as infants transition to independent oral feeding skills. Cue-based feeding is a method that combines the use of non-nutritive sucking (NNS) to promote awake behavior for feeding, the use of behavioral assessment to identify readiness for feeding, and systematic observation of and response to infant behavior cues to regulate frequency, duration, and volume of oral feedings. CBF has been shown to have several benefits, such as earlier transition to oral feedings, reduced length of stay, improved physiological maturity, improved nutritional intake, and reduced stress on the family.

A wide range of infant feeding skill assessment tools exist; however, no gold-standard tool has been identified in the literature due to inadequate psychometric tests and feasibility. The study team developed an infant oral feeding skill assessment tool called the SMART Tool, which provides a numerical score before and after feed. The SMART tool evaluates feeding skills across five domains: State of arousal, motor tone, autonomic instability, response to stimulation, and total oral skills. These domains form the acronym of SMART Tool. The Synactive Theory of Development provided the theoretical basis for the SMART tool's design and also aligns with trauma-informed care principles, neonatal integrative developmental care model, life course health development intervention, and infant-family-centered developmental care. 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). The SMART tool was designed to meet the needs of NICU clinicians, providing an objective measure of the safety and quality of feedings that can replace the traditional volume-driven approach. The SMART Tool was prospectively tested in four Level III Neonatal Intensive care units (NICU) in the Advocate Health system and shown to be valid and reliable for infant feeding skill assessment. This tool has been integrated into daily clinical usage at 15 NICUs within Advocate Health.

Analysis:

No neonatal feeding skill assessment at Discharge Historically, there has been a focus on the quantity (volume) of oral intake versus the quality (skill). The American Academy of Pediatrics requires "oral feeding sufficient to support appropriate growth" for infants as part of its criterion for hospital discharge. (American Academy of Pediatrics Committee on & Newborn, 2008) This criterion perpetuates the focus on volume rather than skill for infant feeding in the NICU.

Clinicians' most significant assumption is that if an infant can complete oral feedings by volume, the infant is developmentally mature and has adequate feeding skills. No universal policy measures the infant's oral feeding skill level at discharge. The study team believes this is essential information for parents and pediatricians to know about infants' feeding skills, like hearing tests or heart screening. The study team believes that every neonatal discharge summary from the NICU should communicate the infant's feeding skill level to outpatient pediatricians so that they can monitor it closely. Doing so provides continuity of care about the safety and quality of feeds.

Plan: Evaluate skills at discharge

In this pilot retrospective study, the study team intends to evaluate the legitimacy of the assumption that if an infant can complete oral feedings by volume, the infant demonstrates mature, capable feeding skills. SMART Tool qualifies the oral feeding skill level as "caution," "developing," and "capable." If the assumption is valid, all infants with full oral feeds at discharge should be in the "capable" category. The first aim is to check if any infants were in the "caution" or "developing" categories at discharge. The second aim is to describe the distribution of feeding skills levels at discharge.

This study's most powerful impact is dispelling the assumption that "full oral feeds" are the same as "full skill development." This will be pilot data to enable us to do a prospective multicenter study to recheck this assumption on a larger dataset and categorize the feeding level in different situations.

In the future, this study can help us with two big impacts - 1. Change national policy on infant discharge to include some concepts of feeding quality, and 2. Identify those at risk of future pediatric feeding disorders earlier and monitor meaningful outcomes for family and society.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates admitted and discharged from Advocate Illinois Masonic Medical Center (AIMMC) Neonatal Intensive Care Unit (NICU)

Description

Inclusion Criteria:

  • Neonates admitted and discharged from Advocate Illinois Masonic Medical Center (AIMMC) Neonatal Intensive Care Unit (NICU) from April 1, 2024 to September 30, 2024

Exclusion Criteria:

  • Discharged without attaining full independent oral feeds by volume. This excludes infant deaths and transfers without attaining full oral feeds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NICU Infants
One cohort of infants who were admitted and discharged during the study period.
Diagnostic test: SMART Tool for Feeding Skill Assessment
Infant Oral Feeding Skill Assessment (FSA) done using SMART Tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capable Feeding Skills at Discharge
Time Frame: At discontinuation of SMART Tool Scoring for up to 6 months.

Based on the Last Feeding Skill Assessment (FSA) Score, calculate the percentage of infants in the "capable" range/ total included infants.

The SMART tool evaluates feeding skills across five domains: State of arousal, motor tone, autonomic instability, response to stimulation, and total oral skills. The score has a minimum value of 25 and a maximum value of 100; higher scores mean a better outcome. 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).
At discontinuation of SMART Tool Scoring for up to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding Skills Distribution at Discharge.
Time Frame: At discontinuation of SMART Tool Scoring for up to 6 months.
Based on the Last Feeding Skill Assessment (FSA) Score, show the distribution of infant feeding levels in three categories: caution, developing, and capable. The SMART tool evaluates feeding skills across five domains: State of arousal, motor tone, autonomic instability, response to stimulation, and total oral skills. The score has a minimum value of 25 and a maximum value of 100; higher scores mean a better outcome. 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).
At discontinuation of SMART Tool Scoring for up to 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Last FSA Score at discontinuation of SMART Tool scoring.
Time Frame: At discontinuation of SMART Tool Scoring for up to 6 months.

Last Feeding Skill Assessment (FSA) Score when SMART Tool scoring was discontinued as per NICU policy.

The SMART tool evaluates feeding skills across five domains: State of arousal, motor tone, autonomic instability, response to stimulation, and total oral skills. The score has a minimum value of 25 and a maximum value of 100; higher scores mean a better outcome. 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).
At discontinuation of SMART Tool Scoring for up to 6 months.
Length of Stay
Time Frame: Duration of hospitalization in days, for up to 6 months.
Length of Stay in Hospital
Duration of hospitalization in days, for up to 6 months.
Time from Start oral feeds to Full oral feeds
Time Frame: From start of oral feeds to removal of Nasogastric tubes in days, for up to 6 months.
Days from initiation of oral feeds to discontinuing nasogastric tube.
From start of oral feeds to removal of Nasogastric tubes in days, for up to 6 months.
Breastfeeding at Discharge
Time Frame: At discharge from the hospital for up to 6 months.
Percentage of infants with any direct breastfeeding at discharge.
At discharge from the hospital for up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Ravi Mishra, MD, FAAP, Advocate Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00120659 (Wake Forest University Health Sciences)
  • AR00057 (Other Identifier: Advocate Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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