Psychometric Properties of the SMART Feeding Tool

NCT05729828 | Completed

• 1 other identifier: 21.001E
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 4

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. 1.To design a feeding tool to assess oral motor and neurobehavioral skills in neonates
2. 2.To establish psychometrics of the new tool by doing reliability and validity tests.

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

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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

Study Arms (1)

Observation group

Neonates with PMA 33 weeks, 0 days or more, present in NICU. No intervention was done.

Eligibility Criteria

• Age: 33 Weeks - 50 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates above 33 weeks, 0 days PMA in NICU

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (4)

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Advocate Children's Hospital - Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Advocate Children's Hospital - Park Ridge

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Trauma and Stressor Related Disorders; Infant Nutrition Disorders; Deglutition Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ravi Mishra, MD, FAAP

  Advocate Health

  PRINCIPAL INVESTIGATOR

• Anne Albi, SLP, IBCLC

  Advocate Health

  PRINCIPAL INVESTIGATOR

• Cynthia Liracrame, MSN, RNC-NIC

  Advocate Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 15, 2023
• Study Start: May 5, 2021
• Primary Completion: January 23, 2022
• Study Completion: February 10, 2022
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)