Ultrasound Assessment of BC in the NICU

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

25 week–34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

validation of portable ultrasound to measure body composition

Primary outcomes

Whole-body measurements of body composition

Time frame: Up to 6 weeks

Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2027
First posted: Aug 7, 2017
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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