PDA for Kidneys Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Near Infrared Spectroscopy.
- Who it may be relevant to
- Registry conditions: Patent Ductus Arteriosus, Congenital Heart Disease. Basic parameters: 1 Minute — 7 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study
Overview
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]
Secondary outcome measures (4)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Meriter Hospital, Inc. — Madison
Identifiers
NCT: NCT06658496 · 2024-1052 · A536757 · Protocol Version 1/20/2026