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Happy Baby Hearts Study

NCT05842876 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

  • Coarctation of Aorta

Interventions

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

Sponsors & Collaborators

  • Meriter Foundation

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Matthew Harer, MD · University of Wisconsin, Madison

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2025-01-21
Completion
2025-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842876 on ClinicalTrials.gov