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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: Active study of Premature Infant, sponsored by University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution.
Conditions Studied
Interventions
- DEVICE ultrasound
Study Locations (1)
Minnesota
- University of Minnesota Masonic Children's Hospital - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2027-12-31 |
What the registry record for NCT03241082 still lists
NCT03241082 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 282-participant average among 9 other Premature Infant trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Premature Infant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03241082's enrollment target sits among peer trials
68 6th of 9 higher than 4 of 9 other Premature Infant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Premature Infant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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