PDA for Kidneys Study

Last updated: May 16, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Pentalogy Of Cantrell

Congenital Heart Disease

Treatment

Near Infrared Spectroscopy

Clinical Study ID

NCT06658496
2024-1052
Protocol Version 7/11/24
Protocol Version 2/10/25
A536757
  • Ages 1-7
  • All Genders

Study Summary

The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.

Researchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Delivered at <32 weeks' gestation

  • ≤72 hours of age

  • Inpatient at Meriter Hospital, Inc. NICU

  • At least one parent/guardian is able to provide parental permission in English orSpanish

Exclusion

Exclusion Criteria:

  • Major congenital anomalies of kidney

  • Attending physician's discretion to not place NIRS sensors due to clinical concerns

  • In the PI or Co-I's medical opinion, there is a significant likelihood that theneonate would not survive the first 3 days of life

  • Birth parent aged <18

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Near Infrared Spectroscopy
Phase:
Study Start date:
December 19, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Meriter Hospital, Inc.

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

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