Happy Baby Hearts Study

University of Wisconsin (UW)

Status: Completed

Conditions: Coarctation of Aorta

Treatments: Device: Continuous Renal NIRS Monitoring; Diagnostic Test: Standard Clinical Care; Other: Satisfaction Survey

Study type: Observational

Funder types: Other

Identifiers

NCT05842876

A536757 (Other Identifier)

Protocol Version 3/29/2024 (Other Identifier)

2022-1710

SMPH\PEDIATRICS\NEONATO (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

82 participants in 3 patient groups

Caregiver + Low Risk neonates

Description:

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

Treatment:

Other: Satisfaction Survey

Diagnostic Test: Standard Clinical Care

Device: Continuous Renal NIRS Monitoring

Diagnostic Test: Standard Clinical Care

Caregiver + Medium to High Risk neonates

Description:

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

Treatment:

Diagnostic Test: Standard Clinical Care

Diagnostic Test: Standard Clinical Care

Nurses in the Newborn Nursery

Description:

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

Treatment:

Other: Satisfaction Survey