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NCT03241082 Clinical Trial

Ultrasound Assessment of BC in the NICU

Premature Infant Clinical Trial

Official title:
Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03241082
Other study ID # PEDS-2017-25699
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 23, 2017
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall objective of the proposal is to evaluate the ability of ultrasound to predict and routinely (weekly) monitor changes in the body composition of healthy preterm infants in the neonatal intensive care unit (NICU) in response to nutritional intake. The investigators hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight gain and assess the adequacy of nutritional provision for premature infants in the neonatal intensive care unit. 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 healthy, premature infants. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP). Stable isotope dilution techniques will be used in a subset of our population as a secondary source of validation. Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen, quadriceps) until discharge in healthy, premature infants.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 68
Est. completion date December 31, 2024
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Weeks to 34 Weeks
Eligibility Inclusion Criteria: - Healthy, premature infants 25-34+6 weeks gestational age at birth - Admitted to the University of Minnesota Masonic Children's Hospital NICU - Stable on room air or can be removed from respiratory support for 5 minutes - Written or verbal (telephone) informed consent can be secured from a parent within 1 week of admission to the NICU Exclusion Criteria: -Require medical support preventing ADP measurements

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ultrasound
validation of portable ultrasound to measure body composition

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 Whole-body measurements of body composition Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution. Up to 6 weeks
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