Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes
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|ClinicalTrials.gov Identifier: NCT03479515|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment|
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|
|Estimated Enrollment :||80 participants|
|Official Title:||Use of Bedside Ultrasound to Monitor Body Composition and Neurodevelopmental Outcomes in Formerly-Premature Toddlers|
|Actual Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2027|
Data will be used to create and evaluate predictive equation
Ultrasound, ADP, bioimpedance measurements
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479515
|Contact: Emily Nagel, MS, RDemail@example.com|
|United States, Minnesota|
|University of Minnesota Masonic Children's Hospital||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Emily Nagel, MS, RD 612-624-3747 firstname.lastname@example.org|
|Principal Investigator: Sara Ramel, MD|
|Principal Investigator:||Sara Ramel, MD||University of Minnesota|