PDA for Kidneys Study
This observational study, called the PDA for Kidneys Study, aims to learn more about how oxygen levels in a baby's kidneys are related to a condition called patent ductus arteriosus (PDA) and potential kidney injury. Researchers will use a device called Near Infrared Spectroscopy (NIRS) to monitor oxygen levels in the brain and kidneys of newborns during their first 72 hours of life. They will also look at heart ultrasounds and analyze urine samples. The main goal is to compare PDA heart measurements with kidney oxygen levels during the first week after birth. This study is for babies born before 32 weeks' gestation, who are 72 hours old or less, and are inpatients at Meriter Hospital, Inc. NICU. At least one parent must be able to give permission in English or Spanish. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study with a planned enrollment of 45 participants. It is not a randomized or blinded study.
- What's involved
- Participants will have Near Infrared Spectroscopy (NIRS) sensors applied to their brain and kidney sites during the first 72 hours after birth to monitor regional tissue oxygenation.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures kidney hypoxia up to Day 7 of age.
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PDA for Kidneys Study
At a glance
Conditions
NCT06658496
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Meriter Hospital, Inc.
Madison, Wisconsinno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Matthew Harer, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Inclusion
Exclusion
What this trial measures
- Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxiaDays 1 to 7 of age
Measured through continuous renal near infrared spectroscopy (NIRS) monitoring in neonates with a PDA to those without. Echos will be obtained every 48 hours during the first 7 days of age for a maximum of 3. RSO2 will be recorded until 7 days of age.