Happy Baby Hearts Study

Completed

• Conditions: Coarctation of Aorta

• Registration Number: NCT05842876
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-19
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-06
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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)

Trial Locations

Locations (2)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Meriter Hospital, Inc.; 🇺🇸 Madison, Wisconsin, United States