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

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ClinicalTrials.gov Identifier: NCT05071508
Recruitment Status : Recruiting
First Posted : October 8, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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
Premature Birth

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : August 2027

Group/Cohort
Preterm Infants
Premature infants (born between 25 and 34 + 6 weeks gestational age) admitted to the University of Minnesota Masonic Children's Hospital NICU



Primary Outcome Measures :
  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



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Ages Eligible for Study:   25 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071508


Contacts
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Contact: Emily M Nagel, PhD 6122737698 nagel127@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Emily Nagel, PhD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Sara E Ramel, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05071508    
Other Study ID Numbers: PEDS-2020-28483
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications