Happy Baby Hearts Study

March 7, 2025 updated by: University of Wisconsin, Madison

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Meriter Hospital, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  1. Neonates admitted to the nursery or NICU at Meriter Hospital, Inc. or UWHealth Kids - American Family Children's Hospital (AFCH) who are ≥ 35 weeks' gestation and have a prenatally identified concern for coarctation of the aorta.
  2. Primary parent/guardian of neonate.
  3. Nursing staff at Meriter Hospital, Inc.'s Newborn Nursery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Caregiver + Low Risk neonates
Participants in the nursery who are expected to be lower risk for CoA
Device: Continuous Renal NIRS Monitoring
Renal oxygenation data collected every 6 seconds
Diagnostic test: Standard Clinical Care
q6 h BP, q6 h Pulse ox, Echo at 24-72h
Diagnostic test: Standard Clinical Care
Renal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h
Other: Satisfaction Survey
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
Diagnostic test: Standard Clinical Care
q6 h BP, q6 h Pulse ox, Echo at 24-72h
Diagnostic test: Standard Clinical Care
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
Other: Satisfaction Survey
Survey to assess which method of monitoring is preferred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of time monitored
Time Frame: Up to 2 weeks post-delivery, on average
Amount of time continuously monitored will be calculated
Up to 2 weeks post-delivery, on average
Count of adverse and unexpected events
Time Frame: Up to 2 weeks post-delivery
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
Time Frame: 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.
Study start to one year later
Parent/caregiver satisfaction with renal NIRS monitoring
Time Frame: 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
Up to 2 weeks post-delivery, on average
Renal oxygen trends
Time Frame: 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)
Through study completion, approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Meriter Foundation

Investigators

  • Principal Investigator: Matthew Harer, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Actual)

January 21, 2025

Study Completion (Actual)

January 21, 2025

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1710
  • A536757 (Other Identifier: UW- Madison)
  • SMPH\PEDIATRICS\NEONATO (Other Identifier: UW Madison)
  • Protocol Version 3/29/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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