Clinical trial NCT05071508: US and Neurodevelopmental Outcomes in the Neonatal Intensive Care Unit (NICU)
Official title: Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 37
Sex: ALL
Minimum age (years): 25
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants

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.

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

Primary outcomes:
measure: Blood pressure at 35 weeks
timeFrame: 35 weeks corrected age
measure: Blood pressure at 4 mo
timeFrame: 4 months corrected age
measure: Weight data inpatient
timeFrame: 35 weeks corrected age
measure: Length data inpatient
timeFrame: 35 weeks corrected age
measure: Weight data outpatient
timeFrame: 4 months corrected age
measure: Length data outpatient
timeFrame: 4 months corrected age
measure: Fat mass inpatient
timeFrame: 35 weeks corrected age
measure: Fat-free mass inpatient
timeFrame: 35 weeks corrected age
measure: Percent body fat inpatient
timeFrame: 4 months corrected age
measure: Fat mass outpatient
timeFrame: 4 months corrected age
measure: Fat-free mass outpatient
timeFrame: 4 months corrected age
measure: Percent body fat outpatient
timeFrame: 4 months corrected age
measure: Ultrasound adipose measures inpatient
timeFrame: 35 weeks corrected age
measure: Ultrasound muscle measures inpatient
timeFrame: 35 weeks corrected age
measure: Ultrasound adipose measures outpatient
timeFrame: 4 months corrected age
measure: Ultrasound muscle measures outpatient
timeFrame: 4 months corrected age
measure: ERP data inpatient
timeFrame: 35 weeks corrected age
measure: ERP data outpatient
timeFrame: 4 months corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sara E Ramel, MD
role: PRINCIPAL_INVESTIGATOR
References: