Patent Ductus ArteriosusPDA4KNCT06658496
PDA for Kidneys Study
An observational study of Patent Ductus Arteriosus and Congenital Heart Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 7 days
- Conditions the study is for
- Patent Ductus Arteriosus, Congenital Heart Disease
- What is being tested?
- Near Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 7 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Patent Ductus Arteriosus, Congenital Heart Disease
- Being tested
- Near Infrared Spectroscopy
- Keywords
- neonate
- Medical subject headings
- Ductus Arteriosus, Patent, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
Also called NIRS
Application of regional NIRS sensors to brain and kidney sites in the first 72 hours after birth to monitor regional tissue oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with PDA | Not described Receives: Device: Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1 to 7 of age
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of hospitalization, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start19 Dec 2024
- Primary completion30 Jul 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Sponsor
- Investigators
- Matthew Harer, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658496
- Sponsor's protocol ID
- 2024-1052
- Other IDs
- A536757, Protocol Version 1/20/2026
- Acronym
- PDA4K
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study
- ClinicalTrials.gov ID
- NCT06658496
- Acronym / sponsor ID
- PDA4K / 2024-1052
- Conditions
- Patent Ductus Arteriosus, Congenital Heart Disease
- Keywords
- neonate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with PDA | – | Device: Near Infrared Spectroscopy |
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared SpectroscopyAlso: NIRSApplication of regional NIRS sensors to brain and kidney sites in the first 72 hours after birth to monitor regional tissue oxygenation. | Device | Neonates with PDA |
Primary outcome
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.
4 secondary outcomes
Correlation of Iowa PDA score to kidney hypoxia
Time frame: Days 1-7 of age
Correlation between urinary biomarkers and Iowa PDA score
Time frame: Days 1-7 of life
Correlation between rates of hypertension and Iowa PDA score
Time frame: Duration of hospitalization, up to 6 months
Correlation between rates of acute kidney injury (AKI) and Iowa PDA score
Time frame: Duration of hospitalization, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Harer, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus and Congenital Heart Disease, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia (time frame: Days 1 to 7 of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.