NCT05842876

Happy Baby Hearts Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-04-19
• Primary completion: 2025-01-21
• Completion: 2025-01-21
• First posted: 2023-05-06
• Last updated: 2025-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study