PDA for Kidneys Study

NCT06658496 | Recruiting DMC

• 3 other identifiers: 2024-1052A536757Protocol Version 2/10/25
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patent Ductus Arteriosus; Congenital Heart Disease

Keywords

neonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation of Iowa PDA score to kidney hypoxia

  Days 1-7 of age

• Correlation between urinary biomarkers and Iowa PDA score

  Days 1-7 of life

• Correlation between rates of hypertension and Iowa PDA score

  Duration of hospitalization, up to 6 months

• Correlation between rates of acute kidney injury (AKI) and Iowa PDA score

  Duration of hospitalization, up to 6 months

Study Arms (1)

Neonates with PDA

Device: Near Infrared Spectroscopy

Interventions

Near Infrared Spectroscopy DEVICE

Application of regional NIRS sensors to brain and kidney sites in the first 72 hours after birth to monitor regional tissue oxygenation.

Also known as: NIRS

Neonates with PDA

Eligibility Criteria

• Age: 1 Minute - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Meriter Hospital, Inc.

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Heart Defects, Congenital

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Matthew Harer, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paige Condit, MD

CONTACT

616-481-9914; pcondit@wisc.edu

Meg Baker

CONTACT

meg.baker@wisc.edu

Study Design

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

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)