Viewing Study NCT05729828



Ignite Creation Date: 2024-05-06 @ 6:36 PM
Last Modification Date: 2024-10-26 @ 2:51 PM
Study NCT ID: NCT05729828
Status: COMPLETED
Last Update Posted: 2023-02-15
First Post: 2023-01-23

Brief Title: Psychometric Properties of the SMART Feeding Tool
Sponsor: Advocate Health Care
Organization: Advocate Health Care

Study Overview

Official Title: Psychometric Properties of the SMART Feeding Tool
Status: COMPLETED
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 tools 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None