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NCT03241082 · ClinicalTrials.gov registry record

Ultrasound Assessment of BC in the NICU

A clinical trial of Premature Infant, sponsored by University of Minnesota.

Active
Registry status
68
Enrollment target
1
Study location

NCT03241082 is a study of Premature Infant that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 68 participants, below the 282-participant average among 9 other Premature Infant trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03241082, a study of Premature Infant, is active but no longer recruiting, sponsored by University of Minnesota.

ACTIVE NOT RECRUITING
Registry status
68 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DEVICE ultrasound

Study Locations (1)

Minnesota

  • University of Minnesota Masonic Children's Hospital - Minneapolis

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2017-10-23
Est. Completion 2027-12-31

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT03241082

The ClinicalTrials.gov registry entry for NCT03241082 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 282-participant average among 9 other Premature Infant trials with a reported enrollment target (76% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Premature Infant appearing as the primary indexed condition, and to 1 intervention - of which ultrasound is the first listed.

NCT03241082 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT03241082 about?

NCT03241082 is a clinical study titled "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 ultraso...

What is the current status of trial NCT03241082?

This trial is currently active not recruiting. The enrollment target is 68 participants. The study started on 2017-10-23. Estimated completion is 2027-12-31.

What conditions does trial NCT03241082 study?

This clinical trial studies the following conditions: Premature Infant.

What interventions are being tested in trial NCT03241082?

The interventions under investigation include: ultrasound (DEVICE).

Who is sponsoring clinical trial NCT03241082?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03241082 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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