NCT06658496 · University of Wisconsin, Madison
PDA for Kidneys Study
(PDA4K)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Madison, Wisconsin
Collaborators
The Gerber Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations