Happy Baby Hearts Study

Study Overview
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Brief Summary
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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.

Official Title
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Renal NIRS Monitoring to Detect Coarctation of the Aorta - A Pilot Study

Conditions
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Coarctation of Aorta

Intervention / Treatment
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* Device: Continuous Renal NIRS Monitoring
* Diagnostic Test: Standard Clinical Care
* Diagnostic Test: Standard Clinical Care
* Other: Satisfaction Survey


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Subject is unable to provide informed consent, including subjects who are in foster care and subjects within state custody Pregnant woman who does not plan to maintain custody of the child after birth, such as instances of adoption or surrogacy Newborn Nursery Nursing Staff: All Newborn Nursery nursing staff at Meriter Hospital, Inc.'s Newborn Nursery are eligible to participate

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caregiver + Low Risk neonates<br>Participants in the nursery who are expected to be lower risk for CoA | Device: Continuous Renal NIRS Monitoring<br>* Renal oxygenation data collected every 6 seconds<br>Diagnostic Test: Standard Clinical Care<br>* q6 h BP, q6 h Pulse ox, Echo at 24-72h<br>Other: Satisfaction Survey<br>* Survey to assess which method of monitoring is preferred<br>|
| Caregiver + Medium to High Risk neonates<br>Participants in the NICU who are expected to be at a higher risk for CoA | Diagnostic Test: Standard Clinical Care<br>* Renal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h<br>|
| Nurses in the Newborn Nursery<br>Nurses who work at the Meriter Hospital, Inc. Newborn Nursery | Other: Satisfaction Survey<br>* Survey to assess which method of monitoring is preferred<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of time monitored | Amount of time continuously monitored will be calculated | Up to 2 weeks post-delivery, on average | 
| Count of adverse and unexpected events | All adverse and unexpected events will be recorded | Up to 2 weeks post-delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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) | Through study completion, approximately 1 year |