Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05071508
Enrollment
37
Registered
2021-10-08
Start date
2020-02-20
Completion date
2022-12-31
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

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.

Interventions

None listed

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Weeks to 34 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure at 35 weeks35 weeks corrected ageblood pressure (systolic and diastolic)
Blood pressure at 4 mo4 months corrected ageblood pressure (systolic and diastolic)
Weight data inpatient35 weeks corrected ageweight in kg
Length data inpatient35 weeks corrected agelength in cm
Weight data outpatient4 months corrected ageweight in kg
Length data outpatient4 months corrected agelength in cm
Fat mass inpatient35 weeks corrected agefat mass (kg)
Fat-free mass inpatient35 weeks corrected agefat-free mass (kg)
Percent body fat inpatient4 months corrected agepercent body fat (kg/kg)
Fat mass outpatient4 months corrected agefat mass (kg)
Fat-free mass outpatient4 months corrected agefat-free mass (kg)
Percent body fat outpatient4 months corrected agepercent body fat (kg/kg)
Ultrasound adipose measures inpatient35 weeks corrected ageadipose tissue (cm)
Ultrasound muscle measures inpatient35 weeks corrected agemuscle thickness (cm)
Ultrasound adipose measures outpatient4 months corrected ageadipose tissue (cm)
Ultrasound muscle measures outpatient4 months corrected agemuscle measurements (cm)
ERP data inpatient35 weeks corrected ageERP paradigm
ERP data outpatient4 months corrected ageERP paradigms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026