Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

University of Minnesota (UMN)

Status: Completed

Conditions: Prematurity

Treatments: Device: Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT03479515

PEDS-2018-25847

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Formerly-Premature Toddlers

Description:

Data will be used to create and evaluate predictive equation

Treatment:

Device: Ultrasound