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

Study Overview
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Brief Summary
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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
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The specific aims are as follows: 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. 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. 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.

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

Conditions
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Premature Birth

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm Infants<br>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?
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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 |