PDA for Kidneys Study

Recruiting

• Conditions: Patent Ductus Arteriosus; Congenital Heart Disease

• Registration Number: NCT06658496
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Study Start: 2024-12-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia	Days 1 to 7 of age	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of Iowa PDA score to kidney hypoxia	Days 1-7 of age	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.
Correlation between urinary biomarkers and Iowa PDA score	Days 1-7 of life	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.
Correlation between rates of hypertension and Iowa PDA score	Duration of hospitalization, up to 6 months	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.
Correlation between rates of acute kidney injury (AKI) and Iowa PDA score	Duration of hospitalization, up to 6 months	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.

Trial Locations

Locations (1)

Meriter Hospital, Inc.; 🇺🇸 Madison, Wisconsin, United States