Ultrasound Assessment of BC in the NICU

NCT03241082 | Active Not Recruiting

• 1 other identifier: PEDS-2017-25699
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant

Outcome Measures

Primary Outcomes (1)

• Whole-body measurements of body composition

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

  Up to 6 weeks

Interventions

ultrasound DEVICE

validation of portable ultrasound to measure body composition

Eligibility Criteria

• Age: 25 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants admitted to the University of Minnesota NICU under the care of the PI and/or her colleagues.

You may qualify if:

• 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

You may not qualify if:

• Require medical support preventing ADP measurements

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sara Ramel, MD

  University of Minnesota Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 7, 2017
• Study Start: October 23, 2017
• Primary Completion: January 31, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)