Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prematurity
• Intervention / Treatment: Device: Ultrasound

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Masonic Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Formerly-Premature Toddlers; Data will be used to create and evaluate predictive equation	Device: Ultrasound; Ultrasound, ADP, bioimpedance measurements

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Sara Ramel, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: PEDS-2018-25847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes