Continuous Renal NIRS Monitoring
DeviceRenal oxygenation data collected every 6 seconds
NCT Number: NCT05842876
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:
* whether continuous renal NIRS monitoring is feasible; * whether NIRS monitoring results in higher nursing and parent/caregiver satisfaction than current standard monitoring; and, * whether participants who develop CoA will spend a smaller proportion of time within the normal range than patients who do not have CoA.
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
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Notify Me15 year and older
All sexes
Observational
Meriter Hospital, Inc., Madison, Wisconsin, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Neonate Inclusion Criteria:
Neonate Exclusion Criteria:
Primary Caregiver Inclusion Criteria:
Primary Caregiver Exclusion Criteria:
Newborn Nursery Nursing Staff:
Renal oxygenation data collected every 6 seconds
q6 h BP, q6 h Pulse ox, Echo at 24-72h
Survey to assess which method of monitoring is preferred
Time frame: Up to 2 weeks post-delivery, on average
Amount of time continuously monitored will be calculated
Time frame: Up to 2 weeks post-delivery
All adverse and unexpected events will be recorded
Time frame: Study start to one year later
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: Up to 2 weeks post-delivery, on average
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: Through study completion, approximately 1 year
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)
University of Wisconsin, Madison
Other
Renal NIRS Monitoring to Detect Coarctation of the Aorta - A Pilot Study
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