PDA for Kidneys Study (PDA4K)

University of Wisconsin (UW)

Status: Enrolling

Conditions: Congenital Heart Disease; Patent Ductus Arteriosus

Treatments: Device: Near Infrared Spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT06658496

2024-1052

Protocol Version 2/10/25 (Other Identifier)

A536757 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 1 minute to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

Neonates with PDA

Treatment:

Device: Near Infrared Spectroscopy