Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
76 participants
OBSERVATIONAL
2021-05-05
2022-02-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Observation group
Neonates with PMA 33 weeks, 0 days or more, present in NICU. No intervention was done.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able to tolerate enteral feedings
3. Parental consent available
Exclusion Criteria
33 Weeks
50 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ravi Mishra, MD, FAAP
Role: PRINCIPAL_INVESTIGATOR
Advocate Health
Anne Albi, SLP, IBCLC
Role: PRINCIPAL_INVESTIGATOR
Advocate Health
Cynthia Liracrame, MSN, RNC-NIC
Role: PRINCIPAL_INVESTIGATOR
Advocate Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21.001E
Identifier Type: -
Identifier Source: org_study_id