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Completed

NCT Number: NCT05071508

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

25 week–34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood pressure at 35 weeks

    Time frame: 35 weeks corrected age

    blood pressure (systolic and diastolic)

  2. Blood pressure at 4 mo

    Time frame: 4 months corrected age

    blood pressure (systolic and diastolic)

  3. Weight data inpatient

    Time frame: 35 weeks corrected age

    weight in kg

  4. Length data inpatient

    Time frame: 35 weeks corrected age

    length in cm

  5. Weight data outpatient

    Time frame: 4 months corrected age

    weight in kg

  6. Length data outpatient

    Time frame: 4 months corrected age

    length in cm

  7. Fat mass inpatient

    Time frame: 35 weeks corrected age

    fat mass (kg)

  8. Fat-free mass inpatient

    Time frame: 35 weeks corrected age

    fat-free mass (kg)

  9. Percent body fat inpatient

    Time frame: 4 months corrected age

    percent body fat (kg/kg)

  10. Fat mass outpatient

    Time frame: 4 months corrected age

    fat mass (kg)

  11. Fat-free mass outpatient

    Time frame: 4 months corrected age

    fat-free mass (kg)

  12. Percent body fat outpatient

    Time frame: 4 months corrected age

    percent body fat (kg/kg)

  13. Ultrasound adipose measures inpatient

    Time frame: 35 weeks corrected age

    adipose tissue (cm)

  14. Ultrasound muscle measures inpatient

    Time frame: 35 weeks corrected age

    muscle thickness (cm)

  15. Ultrasound adipose measures outpatient

    Time frame: 4 months corrected age

    adipose tissue (cm)

  16. Ultrasound muscle measures outpatient

    Time frame: 4 months corrected age

    muscle measurements (cm)

  17. ERP data inpatient

    Time frame: 35 weeks corrected age

    ERP paradigm

  18. ERP data outpatient

    Time frame: 4 months corrected age

    ERP paradigms

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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