Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-20

Study Completion Date

2023-06-06

Brief Summary

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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.

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Detailed Description

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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

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Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Formerly-Premature Toddlers

Data will be used to create and evaluate predictive equation

Ultrasound

Intervention Type DEVICE

Ultrasound, ADP, bioimpedance measurements

Interventions

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Ultrasound

Ultrasound, ADP, bioimpedance measurements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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
* written consent obtained from a parent before or at time of visit

Exclusion Criteria

* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No