RecruitingNCT06658496

PDA for Kidneys Study

Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study


Sponsor

University of Wisconsin, Madison

Enrollment

45 participants

Start Date

Dec 19, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 1 MinuteMax Age: 7 Days

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DEVICENear Infrared Spectroscopy

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


Locations(1)

Meriter Hospital, Inc.

Madison, Wisconsin, United States

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NCT06658496


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