Ultrasound Assessment of BC in the NICU

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03241082

Enrollment

Registered

2017-08-07

Start date

2017-10-23

Completion date

2027-12-31

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infant

Brief 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.

Interventions

DEVICEultrasound

validation of portable ultrasound to measure body composition

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Weeks to 34 Weeks

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026