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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071508
• Other study ID #: PEDS-2020-28483
• Status: Recruiting
• Start date: February 20, 2020
• Est. completion date: August 2027

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: Emily M Nagel, PhD
• Phone: 6122737698
• Email: nagel127[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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