Observing kidney oxygen levels in premature babies with heart conditions
Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study
University of Wisconsin, Madison · NCT06658496
This study looks at kidney oxygen levels in premature babies with a heart condition called PDA to see how it affects their kidney health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 1 Minute to 7 Days |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06658496 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather information on kidney oxygen levels in neonates diagnosed with patent ductus arteriosus (PDA) and assess the relationship between these oxygen levels, the status of PDA, and potential kidney injury. Researchers will utilize ultrasound imaging of the heart, analyze urine samples, and measure kidney oxygen levels using Near Infrared Spectroscopy. The study focuses on infants delivered at less than 32 weeks' gestation and who are currently in the NICU at Meriter Hospital. The findings could provide insights into the impact of PDA on kidney function in premature infants.
Who should consider this trial
Good fit: Ideal candidates are neonates born at less than 32 weeks' gestation and admitted to the NICU at Meriter Hospital.
Not a fit: Patients with major congenital kidney anomalies or those deemed unlikely to survive the first three days of life may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of kidney health in premature infants with PDA, potentially leading to improved management and outcomes.
How similar studies have performed: While this approach is observational and focuses on a specific population, similar studies have shown promise in understanding the implications of PDA on various organ systems.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madison, Wisconsin
- Meriter Hospital, Inc. — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Matthew Harer, MD — University of Wisconsin, Madison
- Study coordinator: Paige Condit, MD
- Email: pcondit@wisc.edu
- Phone: 616-481-9914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patent Ductus Arteriosus, Congenital Heart Disease, neonate