Premature InfantNCT03241082
Ultrasound Assessment of BC in the NICU
An observational study of Premature Infant, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 34 weeks
- Conditions the study is for
- Premature Infant
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants admitted to the University of Minnesota NICU under the care of the PI and/or her colleagues.
Who may be able to join
- 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
Who cannot join
- -Require medical support preventing ADP measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455
About this study
Official title: Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit
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:
Read more
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
- Premature Infant
- Being tested
- ultrasound
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
validation of portable ultrasound to measure body composition
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body measurements of body composition
Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start23 Oct 2017
- Primary completion31 Jan 2022
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Ramel, MD, Principal investigator, University of Minnesota Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241082
- Sponsor's protocol ID
- PEDS-2017-25699
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2017
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03241082
- Acronym / sponsor ID
- PEDS-2017-25699
- Conditions
- Premature Infant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants admitted to the University of Minnesota NICU under the care of the PI and/or her colleagues.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Require medical support preventing ADP measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundvalidation of portable ultrasound to measure body composition | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Ramel, MD principal investigator
University of Minnesota Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body measurements of body composition (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.