Psychometric Properties of the SMART Feeding Tool

February 13, 2023 updated by: Advocate Health Care

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

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

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
      • 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

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

7 months to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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
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
Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8)
Time Frame: 12 months

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
Inter Rater Reliability of SMART Tool
Time Frame: 12 months
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
Time Frame: 12 months
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

Collaborators and Investigators

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

Sponsor

Advocate Health Care

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)

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 (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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