Feeding; Difficult, NewbornNCT05729828
Psychometric Properties of the SMART Feeding Tool
An observational study of Feeding; Difficult, Newborn and Premature Infant Disease, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 33 to 50 weeks
- Conditions the study is for
- Feeding; Difficult, Newborn, Premature Infant Disease, Dysphagia of Newborn
- How many people
- 76 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 May 2021to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 50 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates above 33 weeks, 0 days PMA in NICU
Who may be able to join
- At least 33 weeks, 0 days PMA
- Able to tolerate enteral feedings
- Parental consent available
Who cannot join
- 1) Respiratory support of more than two liter-per-minute oxygen via nasal cannula
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Advocate Children's Hospital - Oak Lawn
Oak Lawn, Illinois, 60453
Advocate Children's Hospital - Park Ridge
Park Ridge, Illinois, 60068
About this study
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:
- To design a feeding tool to assess oral motor and neurobehavioral skills in neonates
- To establish psychometrics of the new tool by doing reliability and validity tests.
Read the 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
- 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
- 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
- Medical subject headings
- Trauma and Stressor Related Disorders, Infant Nutrition Disorders, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Neonates with PMA 33 weeks, 0 days or more, present in NICU. No intervention was done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start5 May 2021
- Primary completion23 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding; Difficult, NewbornStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Mishra, MD, FAAP, Principal investigator, Advocate HealthAnne Albi, SLP, IBCLC, Principal investigator, Advocate HealthCynthia Liracrame, MSN, RNC-NIC, Principal investigator, Advocate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729828
- Sponsor's protocol ID
- 21.001E
- Status last verified
- Dec 2024
- First submitted
- 23 Jan 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the SMART Feeding Tool
- ClinicalTrials.gov ID
- NCT05729828
- Acronym / sponsor ID
- 21.001E
- 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
- Keywords
- neonate, dysphagia, trauma informed care, infant and family centred developmental care, synactive developmental theory, psychometrics, deglutition, pediatric feeding disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 23 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To design a feeding tool to assess oral motor and neurobehavioral skills in neonates
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –Neonates with PMA 33 weeks, 0 days or more, present in NICU. No intervention was done. |
Who may qualify
- Ages
- 33 to 50 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates above 33 weeks, 0 days PMA in NICU
Key inclusion criteria (3 listed)
- At least 33 weeks, 0 days PMA
- Able to tolerate enteral feedings
- Parental consent available
Key exclusion criteria (1 listed)
- 1) Respiratory support of more than two liter-per-minute oxygen via nasal cannula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8) Scores
Time frame: 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.
Inter Rater Reliability of SMART Tool
Time frame: 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.
Test Retest Reliability of SMART Tool
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No. Not sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Mishra, MD, FAAP principal investigator
Advocate Health
Anne Albi, SLP, IBCLC principal investigator
Advocate Health
Cynthia Liracrame, MSN, RNC-NIC principal investigator
Advocate Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding; Difficult, Newborn and Premature Infant Disease, run by Wake Forest University Health Sciences at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Criteria Validity: Compare SMART Tool vs. NEOA Tool (version 5.8) Scores (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.