US and Neurodevelopmental Outcomes in the Neonatal Intensive Care Unit (NICU)

Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit

The objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a population at risk for developmental delay, obesity, and metabolic disease. The investigators expect that a better understanding of these relationships will lead to the incorporation of ultrasound into routine nutritional management of preterm infants and allow for future optimization of their overall health and development.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth

Detailed Description

The specific aims are as follows:

1. To identify clinical factors that are associated with muscle and adipose tissue measurements. The investigators will examine the relationship between clinical factors such as calorie and protein intake during hospitalization, days on parenteral nutrition, C-Reactive Protein and other clinical surrogates for inflammation and both muscle and adipose tissue measured bi-weekly using bedside ultrasound. The investigators will collect anthropometric and ultrasound measurements bi-weekly and whole body composition (utilizing ADP) data at 35 weeks postmenstrual age (PMA)/discharge from the Neonatal Intensive Care Unit. All other clinical data will be collected throughout the hospital stay.
2. To determine whether muscle thickness and cross-sectional area are predictive of improved neurodevelopmental outcomes. The investigators will assess the relationship between ultrasound measurements of muscle with neurodevelopmental outcomes at 35 weeks PMA/discharge and 4 months corrected age. The investigators will utilize Event Related Potentials (ERP) to measure speed of processing and recognition memory as early markers of brain development.
3. To determine whether measurements of adipose tissue are predictive of later adverse metabolic outcomes. The investigators will assess the relationship between adipose tissue thickness and blood pressure and total body adiposity (using air-displacement plethysmography) at 35 weeks PMA/discharge and 4 months corrected age.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Emily M Nagel, PhD; Phone Number: 6122737698; Email: nagel127@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota
      • Contact: Emily Nagel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants

Description

Inclusion Criteria:

• preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
• medically stable at time of air displacement measurements

Exclusion Criteria:

• infants that require medical support preventing ADP measurements from being taken

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Preterm Infants; Premature infants (born between 25 and 34 + 6 weeks gestational age) admitted to the University of Minnesota Masonic Children's Hospital NICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure at 35 weeks	blood pressure (systolic and diastolic)	35 weeks corrected age
Blood pressure at 4 mo	blood pressure (systolic and diastolic)	4 months corrected age
Weight data inpatient	weight in kg	35 weeks corrected age
Length data inpatient	length in cm	35 weeks corrected age
Weight data outpatient	weight in kg	4 months corrected age
Length data outpatient	length in cm	4 months corrected age
Fat mass inpatient	fat mass (kg)	35 weeks corrected age
Fat-free mass inpatient	fat-free mass (kg)	35 weeks corrected age
Percent body fat inpatient	percent body fat (kg/kg)	4 months corrected age
Fat mass outpatient	fat mass (kg)	4 months corrected age
Fat-free mass outpatient	fat-free mass (kg)	4 months corrected age
Percent body fat outpatient	percent body fat (kg/kg)	4 months corrected age
Ultrasound adipose measures inpatient	adipose tissue (cm)	35 weeks corrected age
Ultrasound muscle measures inpatient	muscle thickness (cm)	35 weeks corrected age
Ultrasound adipose measures outpatient	adipose tissue (cm)	4 months corrected age
Ultrasound muscle measures outpatient	muscle measurements (cm)	4 months corrected age
ERP data inpatient	ERP paradigm	35 weeks corrected age
ERP data outpatient	ERP paradigms	4 months corrected age

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Sara E Ramel, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: PEDS-2020-28483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No