Clinical trial NCT05729828: Psychometric Properties of the SMART Feeding Tool
Official title: Psychometric Properties of the SMART Feeding Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding; Difficult, Newborn
Premature Infant Disease
Dysphagia of Newborn
Nurse's Role
Feeding Disorder of Infancy or Early Childhood
Trauma and Stressor Related Disorders
Deglutition Disorders in Infants
Malnutrition, Infant
Keywords: neonate
dysphagia
trauma informed care
infant and family centred developmental care
synactive developmental theory
psychometrics
deglutition
pediatric feeding disorder
SMART Tool
life course health development
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 76
Sex: ALL
Minimum age (years): 33
Maximum age (years): 50
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates above 33 weeks, 0 days PMA in NICU

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8) Scores
timeFrame: 12 months
measure: Inter Rater Reliability of SMART Tool
timeFrame: 12 months
measure: Test Retest Reliability of SMART Tool
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital - Oak Lawn
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Children's Hospital - Park Ridge
state: Illinois
Study officials:
affiliation: Advocate Health
name: Ravi Mishra, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
affiliation: Advocate Health
name: Anne Albi, SLP, IBCLC
role: PRINCIPAL_INVESTIGATOR
affiliation: Advocate Health
name: Cynthia Liracrame, MSN, RNC-NIC
role: PRINCIPAL_INVESTIGATOR
References: