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临床试验/NCT05729828
NCT05729828已完成不适用

Psychometric Properties of the SMART Feeding Tool

Wake Forest University Health Sciences4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
4
主要终点
Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8) Scores

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
33 Weeks 至 50 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • At least 33 weeks, 0 days PMA
  • Able to tolerate enteral feedings
  • Parental consent available

排除标准

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

结局指标

主要结局

Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8) Scores

时间窗: 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.

Test Retest Reliability of SMART Tool

时间窗: 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.

Inter Rater Reliability of SMART Tool

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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