Psychometric Properties of the SMART Feeding Tool

Nurse's Role Clinical Trial

Official title:

Psychometric Properties of the SMART Feeding Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729828
• Other study ID #: 21.001E
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2023
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 10, 2022
• Est. primary completion date: January 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 33 Weeks to 50 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	Advocate Children's Hospital - Oak Lawn	Oak Lawn	Illinois
United States	Advocate Children's Hospital - Park Ridge	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8)	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
Primary	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
Primary	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