Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes
Use of Bedside Ultrasound to Monitor Body Composition and Neurodevelopmental Outcomes in Formerly-Premature Toddlers
1 other identifier
observational
80
1 country
1
Brief Summary
The overall objective of the proposal is to evaluate the ability of ultrasound to predict the body composition of toddlers in the outpatient clinical setting and to evaluate the relationship between body composition and neurodevelopment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
July 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2023
CompletedFebruary 19, 2025
February 1, 2025
4.9 years
March 12, 2018
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Ultrasound Measurements
Tissue thickness (adipose and muscle) will be measured in cm using the ultrasound probe.
through study completion, up to 2 years
Secondary Outcomes (3)
Body Composition Measurements
through study completion, up to 2 years
Neurodevelopmental Status for 2 year olds
through study completion, up to 2 years
Neurodevelopmental Status for 3 and 4 year olds
through study completion, up to 2 years
Study Arms (1)
Formerly-Premature Toddlers
Data will be used to create and evaluate predictive equation
Interventions
Eligibility Criteria
Toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
You may qualify if:
- toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
- written consent obtained from a parent before or at time of visit
You may not qualify if:
- toddlers who require medical support that prevents them from having ADP measurements taken
- those with an inability to sit in a supported seat for 5 minutes
- those weighing less than 10 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Ramel, MD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2018
First Posted
March 27, 2018
Study Start
July 20, 2018
Primary Completion
June 6, 2023
Study Completion
June 6, 2023
Last Updated
February 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share