Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

Active, not recruiting

• Conditions: Prematurity
• Interventions: Device: Ultrasound

• Registration Number: NCT03479515
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Study Start: 2018-07-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Formerly-Premature Toddlers	Ultrasound	Data will be used to create and evaluate predictive equation

Primary Outcome Measures

Name	Time	Method
Ultrasound Measurements	through study completion, up to 2 years	Tissue thickness (adipose and muscle) will be measured in cm using the ultrasound probe.

Secondary Outcome Measures

Name	Time	Method
Body Composition Measurements	through study completion, up to 2 years	Fat and fat-free mass will be measured in kilograms using bioimpedance and air displacement plethysmography.
Neurodevelopmental Status for 3 and 4 year olds	through study completion, up to 2 years	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.
Neurodevelopmental Status for 2 year olds	through study completion, up to 2 years	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).

Trial Locations

Locations (1)

University of Minnesota Masonic Children's Hospital; 🇺🇸 Minneapolis, Minnesota, United States