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| ID | Type | Description | Link |
|---|---|---|---|
| A536757 | Other Identifier | UW- Madison | |
| Protocol Version 1/20/2026 | Other Identifier | UW- Madison |
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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates with PDA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates born <32 weeks gestational age (GA) at Meriter Hospital, Inc. and outborn neonates admitted to Meriter Hospital, Inc. within 12 hours of life.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paige Condit, MD | Contact | 616-481-9914 | pcondit@wisc.edu | |
| Meg Baker | Contact | meg.baker@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Harer, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meriter Hospital, Inc. | Recruiting | Madison | Wisconsin | 53715 | United States |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |