Trials / Active Not Recruiting
Active Not RecruitingNCT03241082
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 25 Weeks – 34 Weeks
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ultrasound | validation of portable ultrasound to measure body composition |
Timeline
- Start date
- 2017-10-23
- Primary completion
- 2022-01-31
- Completion
- 2027-12-31
- First posted
- 2017-08-07
- Last updated
- 2026-01-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03241082. Inclusion in this directory is not an endorsement.