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. The main questions it aims to answer are:

1. To design a feeding tool to assess oral motor and neurobehavioral skills in neonates
2. To establish psychometrics of the new tool by doing reliability and validity tests.

Study Overview

• Status: Completed
• Conditions: Trauma and Stressor Related Disorders; Nurse's Role; Premature Infant Disease; Feeding; Difficult, Newborn; Malnutrition, Infant; Dysphagia of Newborn; Feeding Disorder of Infancy or Early Childhood; Deglutition Disorders in Infants

Detailed Description

Research supports the use of infant-directed feeding practices versus a volume-driven approach. Infant-directed feeding practices provide developmentally supportive and neuroprotective care to fragile feeders. In addition, various assessment tools exist to evaluate both breast and bottle feeding. Assessment tools are crucial to feeders with guidance in their decision-making, identifying when an infant is ready to feed and recognizing any feeding-related safety concerns.

The scoring of a tool should provide an opportunity to reflect on the strengths and areas of deficit in feeding events and allow feeders to modify feeding practices for the next attempt or pursue further assessment by a feeding specialist. Few tools exist to evaluate both oral skills and neurobehavioral skills. Some tools available have inadequate psychometric data to support their use. If robust psychometrics exist, the length and complexity of the device may intimidate users and deter consistent use.

The SMART tool was developed to capture the multifaceted aspects of feeding while remaining brief in its administration time. The tool provides an opportunity to evaluate skills and develop a plan after feeding to provide consistent quality care. Additionally, tracking scores over time helps in patient safety for the goal of a high-reliability organization.

This study has two objectives: 1. to create a new tool using synactive development theory and trauma-informed care approach for neonates and 2. to establish this tool's psychometrics (validity and reliability). This multicenter trial will be done over four sites (NICU) in Advocate Aurora Health (AAH) to observe feeding events in neonates. Before and after each feed, scoring of feeding quality will be done to do psychometrics. If the study succeeds, this tool will be employed in clinical care in all the NICUs of AAH.

Acronyms & Abbreviations:

• AAH: Advocate Aurora Health
• NEOA: Neonatal Eating Outcome Assessment Tool
• NICU: Neonatal Intensive care unit
• PMA: Postmenstrual age (weeks)
• SMART: State of Arousal, Motor Tone, Autonomic Instability, Response to Stimulation, Total Oral Skills

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Advocate Illinois Masonic Medical Center
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital - Oak Lawn
    • Park Ridge, Illinois, United States, 60068
      • Advocate Children's Hospital - Park Ridge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 11 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Neonates above 33 weeks, 0 days PMA in NICU

Description

Inclusion Criteria:

1. At least 33 weeks, 0 days PMA
2. Able to tolerate enteral feedings
3. Parental consent available

Exclusion Criteria:

1) Respiratory support of more than two liter-per-minute oxygen via nasal cannula

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observation group; Neonates with PMA 33 weeks, 0 days or more, present in NICU. No intervention was done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter Rater Reliability of SMART Tool	Using SMART Tool, two observers will rate one feeding event of an infant. Observers = 2, Feedings events = 10. Observers will not do any intervention. Data analysis: pre-feed and post-feed scores per feeding event.	12 months
Test Retest Reliability of SMART Tool	Using SMART Tool, one observer will rate two feeding events of the same infant. Observer = 1, Feedings events = 20 The observer will not do any intervention. Data analysis: pre-feed and post-feed scores per feeding event.	12 months
Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8) Scores	The scale of the two tools is as follows: NEOA: feeding challenge (18 to 57), questionable (58 to 76), normal (77 to 90). SMART: caution (under 60), developing (60 to 90), capable (above 90). Higher scores are better on both scales. Sample size = 50 feeding events. Observers will not do any intervention. Data analysis: post-feed scores per feeding event.	12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ravi Mishra, MD, FAAP, Advocate Health; Principal Investigator: Anne Albi, SLP, IBCLC, Advocate Health; Principal Investigator: Cynthia Liracrame, MSN, RNC-NIC, Advocate Health

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): January 23, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: psychometrics; neonate; dysphagia; deglutition; trauma informed care; infant and family centred developmental care; synactive developmental theory; pediatric feeding disorder; SMART Tool; life course health development
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Digestive System Diseases; Gastrointestinal Diseases; Infant, Newborn, Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Trauma and Stressor Related Disorders; Malnutrition; Deglutition Disorders; Infant, Premature, Diseases; Feeding and Eating Disorders; Infant Nutrition Disorders
• Other Study ID Numbers: 21.001E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No