Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

University of Minnesota80 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prematurity

Interventions

UltrasoundDEVICE

Ultrasound, ADP, bioimpedance measurements

Eligibility

Sex: ALLMin age: 2 YearsMax age: 4 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Ultrasound Measurements

Tissue thickness (adipose and muscle) will be measured in cm using the ultrasound probe.

Time frame: through study completion, up to 2 years

Secondary Outcomes

Body Composition Measurements

Fat and fat-free mass will be measured in kilograms using bioimpedance and air displacement plethysmography.

Time frame: through study completion, up to 2 years

Neurodevelopmental Status for 2 year olds

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).

Time frame: through study completion, up to 2 years

Neurodevelopmental Status for 3 and 4 year olds

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.

Time frame: through study completion, up to 2 years

Data from ClinicalTrials.gov

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