Nurse's Role Clinical Trial
Official title:
Psychometric Properties of the SMART Feeding Tool
NCT number | NCT05729828 |
Other study ID # | 21.001E |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2021 |
Est. completion date | February 10, 2022 |
Verified date | February 2023 |
Source | Advocate Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Advocate Health Care |
United States,
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 |
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