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Clinical Trials/NCT03479515
NCT03479515
Completed
Not Applicable

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

University of Minnesota1 site in 1 country80 target enrollmentJuly 20, 2018
ConditionsPrematurity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity
Sponsor
University of Minnesota
Enrollment
80
Locations
1
Primary Endpoint
Ultrasound Measurements
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2018
End Date
June 6, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ultrasound Measurements

Time Frame: through study completion, up to 2 years

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

Secondary Outcomes

  • Body Composition Measurements(through study completion, up to 2 years)
  • Neurodevelopmental Status for 3 and 4 year olds(through study completion, up to 2 years)
  • Neurodevelopmental Status for 2 year olds(through study completion, up to 2 years)

Study Sites (1)

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