Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03479515
• Other study ID #: PEDS-2018-25847
• Status: Active, not recruiting
• Start date: July 20, 2018
• Est. completion date: January 2027

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Device:
• Ultrasound
Ultrasound, ADP, bioimpedance measurements

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Measurements	Tissue thickness (adipose and muscle) will be measured in cm using the ultrasound probe.	through study completion, up to 2 years
Secondary	Body Composition Measurements	Fat and fat-free mass will be measured in kilograms using bioimpedance and air displacement plethysmography.	through study completion, up to 2 years
Secondary	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).	through study completion, up to 2 years
Secondary	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.	through study completion, up to 2 years