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Completed

NCT Number: NCT05842876

Happy Baby Hearts 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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meriter Hospital, Inc., Madison, Wisconsin, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Renal NIRS Monitoring

Device

Renal oxygenation data collected every 6 seconds

Standard Clinical Care

Diagnostic Test

q6 h BP, q6 h Pulse ox, Echo at 24-72h

satisfaction survey

Other

Survey to assess which method of monitoring is preferred

Primary outcomes

  1. Percent of time monitored

    Time frame: Up to 2 weeks post-delivery, on average

    Amount of time continuously monitored will be calculated

  2. Count of adverse and unexpected events

    Time frame: Up to 2 weeks post-delivery

    All adverse and unexpected events will be recorded

Secondary outcomes

  1. 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.

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Meriter Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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