An observational study in Coarctation of Aorta, sponsored by University of Wisconsin, Madison. Completed at 2 sites in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by University of Wisconsin, Madison · Observational
The goal of this observational study is to determine the feasibility of renal Near Infrared Spectroscopy (NIRS) monitoring in the newborn nursery for newborns at low risk of coarctation of the aorta (CoA). The main questions it aims to answer are:
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 82 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Neonate Inclusion Criteria:
Neonate Exclusion Criteria:
Primary Caregiver Inclusion Criteria:
Primary Caregiver Exclusion Criteria:
Newborn Nursery Nursing Staff:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the nursery who are expected to be lower risk for CoA
Device: Continuous Renal NIRS Monitoring · Diagnostic Test: Standard Clinical Care · Other: Satisfaction Survey
Participants in the NICU who are expected to be at a higher risk for CoA
Diagnostic Test: Standard Clinical Care
Nurses who work at the Meriter Hospital, Inc. Newborn Nursery
Other: Satisfaction Survey
Renal oxygenation data collected every 6 seconds
q6 h BP, q6 h Pulse ox, Echo at 24-72h
Renal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h
Survey to assess which method of monitoring is preferred
Percent of time monitored
Amount of time continuously monitored will be calculated
Time frame: Up to 2 weeks post-delivery, on average
Count of adverse and unexpected events
All adverse and unexpected events will be recorded
Time frame: Up to 2 weeks post-delivery
Change in nursing satisfaction with renal NIRS monitoring
A subjective description of survey responses in addition to determining which method of monitoring is preferred: NIRS vs. Enhanced BP/Pulse ox checks. Survey will be conducted at the beginning of the study, and one year later.
Time frame: Study start to one year later
Parent/caregiver satisfaction with renal NIRS monitoring
A subjective description of survey responses in addition to determining which method of monitoring is preferred: NIRS vs. Enhanced BP/Pulse ox checks
Time frame: Up to 2 weeks post-delivery, on average
Renal oxygen trends
A permutation test will be used to compare the distribution of proportions (of time spent within normal range) between the two groups (CoA vs. normal)
Time frame: Through study completion, approximately 1 year
Plan to share: No
Ran from Apr 2023 to primary completion in Jan 2025, 21 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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