Happy Baby Hearts Study

University of Wisconsin, Madison82 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coarctation of Aorta

Interventions

Continuous Renal NIRS MonitoringDEVICE

Renal oxygenation data collected every 6 seconds

Standard Clinical CareDIAGNOSTIC_TEST

q6 h BP, q6 h Pulse ox, Echo at 24-72h

Standard Clinical CareDIAGNOSTIC_TEST

Renal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Wisconsin

Madison, Wisconsin, United States

Meriter Hospital, Inc.

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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