PDA for Kidneys Study

NCT ID: NCT06658496

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-19

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patent Ductus Arteriosus Congenital Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates with PDA

Near Infrared Spectroscopy

Intervention Type DEVICE

Application of regional NIRS sensors to brain and kidney sites in the first 72 hours after birth to monitor regional tissue oxygenation.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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NIRS

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Harer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Meriter Hospital, Inc.

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paige Condit, MD

Role: CONTACT

616-481-9914

Meg Baker

Role: CONTACT

Other Identifiers

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A536757

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 2/10/25

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1052

Identifier Type: -

Identifier Source: org_study_id

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