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

NCT05071508 | Completed

• 1 other identifier: PEDS-2020-28483
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (18)

• Blood pressure at 35 weeks

  blood pressure (systolic and diastolic)

  35 weeks corrected age

• Blood pressure at 4 mo

  blood pressure (systolic and diastolic)

  4 months corrected age

• Weight data inpatient

  weight in kg

  35 weeks corrected age

• Length data inpatient

  length in cm

  35 weeks corrected age

• Weight data outpatient

  weight in kg

  4 months corrected age

• Length data outpatient

  length in cm

  4 months corrected age

• Fat mass inpatient

  fat mass (kg)

  35 weeks corrected age

• Fat-free mass inpatient

  fat-free mass (kg)

  35 weeks corrected age

• Percent body fat inpatient

  percent body fat (kg/kg)

  4 months corrected age

• Fat mass outpatient

  fat mass (kg)

  4 months corrected age

• Fat-free mass outpatient

  fat-free mass (kg)

  4 months corrected age

• Percent body fat outpatient

  percent body fat (kg/kg)

  4 months corrected age

• Ultrasound adipose measures inpatient

  adipose tissue (cm)

  35 weeks corrected age

• Ultrasound muscle measures inpatient

  muscle thickness (cm)

  35 weeks corrected age

• Ultrasound adipose measures outpatient

  adipose tissue (cm)

  4 months corrected age

• Ultrasound muscle measures outpatient

  muscle measurements (cm)

  4 months corrected age

• ERP data inpatient

  ERP paradigm

  35 weeks corrected age

• ERP data outpatient

  ERP paradigms

  4 months corrected age

Study Arms (1)

Preterm Infants

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

Eligibility Criteria

• Age: 25 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants

You may qualify if:

• 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

You may not qualify if:

• infants that require medical support preventing ADP measurements from being taken

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Sara E Ramel, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: October 8, 2021
• Study Start: February 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)