Happy Baby Hearts Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-19

Study Completion Date

2025-01-21

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.

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Detailed Description

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Conditions

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Coarctation of Aorta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Caregiver + Low Risk neonates

Participants in the nursery who are expected to be lower risk for CoA

Continuous Renal NIRS Monitoring

Intervention Type DEVICE

Renal oxygenation data collected every 6 seconds

Standard Clinical Care

Intervention Type DIAGNOSTIC_TEST

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

Satisfaction Survey

Intervention Type OTHER

Survey to assess which method of monitoring is preferred

Caregiver + Medium to High Risk neonates

Participants in the NICU who are expected to be at a higher risk for CoA

Standard Clinical Care

Intervention Type DIAGNOSTIC_TEST

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

Nurses in the Newborn Nursery

Nurses who work at the Meriter Hospital, Inc. Newborn Nursery

Satisfaction Survey

Intervention Type OTHER

Survey to assess which method of monitoring is preferred

Interventions

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Continuous Renal NIRS Monitoring

Renal oxygenation data collected every 6 seconds

Intervention Type DEVICE

Standard Clinical Care

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

Intervention Type DIAGNOSTIC_TEST

Standard Clinical Care

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

Intervention Type DIAGNOSTIC_TEST

Satisfaction Survey

Survey to assess which method of monitoring is preferred

Intervention Type OTHER

Eligibility Criteria

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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

* 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

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

* 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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No