Clincosm LogoSign in Get a demo

Ultrasound Assessment of BC in the NICU

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03241082
Collaborator
(none)
68
Enrollment
1
Location
86.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasound

Study Design

Study Type:
Observational
Actual Enrollment :
68 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit
Actual Study Start Date :
Oct 23, 2017
Actual Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Whole-body measurements of body composition [Up to 6 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Weeks to 34 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Masonic Children's Hospital Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Sara Ramel, MD, University of Minnesota Department of Pediatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT03241082
Other Study ID Numbers:
  • PEDS-2017-25699
First Posted:
Aug 7, 2017
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 3, 2022