PDA for Kidneys Study (PDA4K)

Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Patent Ductus Arteriosus
• Intervention / Treatment: Device: Near Infrared Spectroscopy

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Meg Baker; Email: meg.baker@wisc.edu
• Study Contact Backup: Name: Paige Condit, MD; Phone Number: 616-481-9914; Email: pcondit@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • Meriter Hospital, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Neonates born <32 weeks gestational age (GA) at Meriter Hospital, Inc. and outborn neonates admitted to Meriter Hospital, Inc. within 12 hours of life.

Description

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 or Spanish

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 the neonate would not survive the first 3 days of life
• Birth parent aged <18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonates with PDA	Device: Near Infrared Spectroscopy; Application of regional NIRS sensors to brain and kidney sites in the first 72 hours after birth to monitor regional tissue oxygenation.; Other Names: NIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia	Measured through continuous renal near infrared spectroscopy (NIRS) monitoring in neonates with a PDA to those without. Echos will be obtained every 48 hours during the first 7 days of age for a maximum of 3. RSO2 will be recorded until 7 days of age.	Days 1 to 7 of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Iowa PDA score to kidney hypoxia	The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (>6) for each echo obtained. Lower scores are optimal. RSO2 correlation will be made with PDA score during the first 7 days of age.	Days 1-7 of age
Correlation between urinary biomarkers and Iowa PDA score	The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (>6). Urinary NGAL, cystatin C, and beta 2 micro globulin levels will be measured daily for the first 7 days of age and a correlation with the Iowa PDA score to levels of these biomarkers will be made.	Days 1-7 of life
Correlation between rates of hypertension and Iowa PDA score	The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (>6). Hypertension will be assessed for throughout hospitalization and a correlation with Iowa PDA score and the diagnosis of hypertension will be made.	Duration of hospitalization, up to 6 months
Correlation between rates of acute kidney injury (AKI) and Iowa PDA score	The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (>6). The diagnosis of AKI will be made using either or both urine output criteria or serum creatinine criteria and a correlation will be made with the IOWA PDA score in the first 7 days of age.	Duration of hospitalization, up to 6 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Matthew Harer, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: neonate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Ductus Arteriosus, Patent; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Chemistry Techniques, Analytical; Spectrum Analysis; Spectroscopy, Near-Infrared
• Other Study ID Numbers: 2024-1052; A536757 (Other Identifier: UW- Madison); Protocol Version 1/20/2026 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No