Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT06658496

Conditions

Patent Ductus Arteriosus

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Near Infrared Spectroscopy

Study Details

Brief 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.

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

Study ID

NCT06658496

Start date

Dec 19, 2024

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Neonates with PDA

Interventions

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 measure

  • Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia [ Time Frame: Days 1 to 7 of age ]

Central Contacts and Locations

Central contacts

Paige Condit, MD

616-481-9914pcondit@wisc.edu

Meg Baker

meg.baker@wisc.edu

Locations

Meriter Hospital, Inc.

Recruiting

Madison, Wisconsin, United States, 53715

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • neonate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-15.