US and Neurodevelopmental Outcomes in the Neonatal Intensive Care Unit (NICU)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The specific aims are as follows:
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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.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Preterm Infants Premature infants (born between 25 and 34 + 6 weeks gestational age) admitted to the University of Minnesota Masonic Children's Hospital NICU |
Outcome Measures
Primary Outcome Measures
- Blood pressure at 35 weeks [35 weeks corrected age]
blood pressure (systolic and diastolic)
- Blood pressure at 4 mo [4 months corrected age]
blood pressure (systolic and diastolic)
- Weight data inpatient [35 weeks corrected age]
weight in kg
- Length data inpatient [35 weeks corrected age]
length in cm
- Weight data outpatient [4 months corrected age]
weight in kg
- Length data outpatient [4 months corrected age]
length in cm
- Fat mass inpatient [35 weeks corrected age]
fat mass (kg)
- Fat-free mass inpatient [35 weeks corrected age]
fat-free mass (kg)
- Percent body fat inpatient [4 months corrected age]
percent body fat (kg/kg)
- Fat mass outpatient [4 months corrected age]
fat mass (kg)
- Fat-free mass outpatient [4 months corrected age]
fat-free mass (kg)
- Percent body fat outpatient [4 months corrected age]
percent body fat (kg/kg)
- Ultrasound adipose measures inpatient [35 weeks corrected age]
adipose tissue (cm)
- Ultrasound muscle measures inpatient [35 weeks corrected age]
muscle thickness (cm)
- Ultrasound adipose measures outpatient [4 months corrected age]
adipose tissue (cm)
- Ultrasound muscle measures outpatient [4 months corrected age]
muscle measurements (cm)
- ERP data inpatient [35 weeks corrected age]
ERP paradigm
- ERP data outpatient [4 months corrected age]
ERP paradigms
Eligibility Criteria
Criteria
Inclusion Criteria:
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preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
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medically stable at time of air displacement measurements
Exclusion Criteria:
- infants that require medical support preventing ADP measurements from being taken
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55454 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Sara E Ramel, MD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PEDS-2020-28483