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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
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment
Prematurity 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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort Intervention/treatment
Formerly-Premature Toddlers
Data will be used to create and evaluate predictive equation
 Device: Ultrasound
Ultrasound, ADP, bioimpedance measurements


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Emily Nagel, MS, RD 612-624-3747 nagel127@umn.edu

Locations
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United States, Minnesota
University of Minnesota Masonic Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily Nagel, MS, RD    612-624-3747    nagel127@umn.edu   
Principal Investigator: Sara Ramel, MD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Sara Ramel, MD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03479515    
Other Study ID Numbers: PEDS-2018-25847
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications