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Clinical Trials/NCT05071508
NCT05071508
Completed
Not Applicable

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

University of Minnesota1 site in 1 country37 target enrollmentFebruary 20, 2020
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University of Minnesota
Enrollment
37
Locations
1
Primary Endpoint
Blood pressure at 4 mo
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2020
End Date
December 31, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Blood pressure at 4 mo

Time Frame: 4 months corrected age

blood pressure (systolic and diastolic)

Percent body fat inpatient

Time Frame: 4 months corrected age

percent body fat (kg/kg)

Fat-free mass outpatient

Time Frame: 4 months corrected age

fat-free mass (kg)

Percent body fat outpatient

Time Frame: 4 months corrected age

percent body fat (kg/kg)

Ultrasound adipose measures outpatient

Time Frame: 4 months corrected age

adipose tissue (cm)

Ultrasound adipose measures inpatient

Time Frame: 35 weeks corrected age

adipose tissue (cm)

Ultrasound muscle measures inpatient

Time Frame: 35 weeks corrected age

muscle thickness (cm)

Length data outpatient

Time Frame: 4 months corrected age

length in cm

Fat mass inpatient

Time Frame: 35 weeks corrected age

fat mass (kg)

ERP data inpatient

Time Frame: 35 weeks corrected age

ERP paradigm

Weight data inpatient

Time Frame: 35 weeks corrected age

weight in kg

Length data inpatient

Time Frame: 35 weeks corrected age

length in cm

Weight data outpatient

Time Frame: 4 months corrected age

weight in kg

ERP data outpatient

Time Frame: 4 months corrected age

ERP paradigms

Blood pressure at 35 weeks

Time Frame: 35 weeks corrected age

blood pressure (systolic and diastolic)

Fat-free mass inpatient

Time Frame: 35 weeks corrected age

fat-free mass (kg)

Fat mass outpatient

Time Frame: 4 months corrected age

fat mass (kg)

Ultrasound muscle measures outpatient

Time Frame: 4 months corrected age

muscle measurements (cm)

Study Sites (1)

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