NCT03479515

Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

Use of Bedside Ultrasound to Monitor Body Composition and Neurodevelopmental Outcomes in Formerly-Premature Toddlers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prematurity

Interventions

Type	Name	Description
DEVICE	Ultrasound	Ultrasound, ADP, bioimpedance measurements

Timeline

• Start date: 2018-07-20
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2018-03-27
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study