Skip to main content
OpenTrials
Completed

NCT Number: NCT03479515

Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

Ultrasound, ADP, bioimpedance measurements

Primary outcomes

  1. 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

  1. Body Composition Measurements

    Time frame: through study completion, up to 2 years

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

  2. Neurodevelopmental Status for 2 year olds

    Time frame: 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).

  3. Neurodevelopmental Status for 3 and 4 year olds

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2018
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.