Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The investigators will address the hypothesis in the following Specific Aims:
Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat-free mass in toddlers. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP).
Specific Aim 2: Determine the effect of a handheld Force-Measuring Ultrasound Probe on intra- and inter-observer variability in ultrasound measurements. A device which measures the force applied to the ultrasound probe will be used to obtain measurements of muscle and adipose tissue thickness (biceps, abdomen, and quadriceps) in toddlers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Formerly-Premature Toddlers Data will be used to create and evaluate predictive equation |
Device: Ultrasound
Ultrasound, ADP, bioimpedance measurements
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Outcome Measures
Primary Outcome Measures
- Ultrasound Measurements [through study completion, up to 2 years]
Tissue thickness (adipose and muscle) will be measured in cm using the ultrasound probe.
Secondary Outcome Measures
- Body Composition Measurements [through study completion, up to 2 years]
Fat and fat-free mass will be measured in kilograms using bioimpedance and air displacement plethysmography.
- Neurodevelopmental Status for 2 year olds [through study completion, up to 2 years]
Bayley Scales of Neurodevelopment III will be used to measure neurodevelopmental status at 2 years of age, including cognition, language, and motor scores (composite scoring for each area: Cognitive, 55-145; Language, 47-153; Motor, 46-154).
- Neurodevelopmental Status for 3 and 4 year olds [through study completion, up to 2 years]
Weschler Preschool and Primary Scale of Intelligence (WPPSI) at 3 and 4 years of age will be used to measure neurodevelopmental status for toddlers 3, 4, or 5 years of age. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3.
Eligibility Criteria
Criteria
Inclusion Criteria:
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toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
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written consent obtained from a parent before or at time of visit
Exclusion Criteria:
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toddlers who require medical support that prevents them from having ADP measurements taken
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those with an inability to sit in a supported seat for 5 minutes
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those weighing less than 10 kg
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Sara Ramel, MD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PEDS-2018-25847