Coarctation of Aorta
Conditions
Brief summary
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.
Interventions
OTHERSatisfaction Survey
Survey to assess which method of monitoring is preferred
DEVICEContinuous Renal NIRS Monitoring
Renal oxygenation data collected every 6 seconds
DIAGNOSTIC_TESTStandard Clinical Care
q6 h BP, q6 h Pulse ox, Echo at 24-72h
Sponsors
Meriter Foundation
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Neonate Inclusion Criteria: * Delivered at ≥ 35 weeks of gestation * \<12 hours of age * Inpatient at Meriter Hospital, Inc. NICU or Newborn Nursery or AFCH PICU or NICU * Diagnosed as at risk for CoA Neonate
Exclusion criteria
* Major congenital anomalies of the kidney * Attending physician's discretion to not place sensors due to clinical concerns * In the researcher's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life Primary Caregiver Inclusion Criteria: * Able to understand and the willing to sign a written informed consent document * Willing to comply with all study procedures and be available for the duration of the study * Birth parent (i.e., the parent who gave birth to the baby) who is the primary caregiver of a neonate who is eligible to participate in study * Agrees to enroll neonate into study * Aged 15 years or older * Pregnant mother with a baby diagnosed prenatally as at risk for CoA will be eligible for the study. They must also meet the following criteria: * Require an arch watch care plan as a results of prenatal ultrasonography findings * Agree to enroll offspring into the study at birth Primary Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of time monitored | Up to 2 weeks post-delivery, on average | Amount of time continuously monitored will be calculated |
| Count of adverse and unexpected events | Up to 2 weeks post-delivery | All adverse and unexpected events will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in nursing satisfaction with renal NIRS monitoring | 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. |
| Parent/caregiver satisfaction with renal NIRS monitoring | 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 |
| Renal oxygen trends | 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) |
Countries
United States
Outcome results
None listed