Coarctation of AortaNCT05842876
Happy Baby Hearts Study
An observational study of Coarctation of Aorta, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Coarctation of Aorta
- What is being tested?
- Continuous Renal NIRS Monitoring, Standard Clinical Care and Satisfaction Survey
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2023to 21 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin
Madison, Wisconsin, 53705
Meriter Hospital, Inc.
Madison, Wisconsin, 53715
About this study
Official title: 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.
- Conditions
- Coarctation of Aorta
- Being tested
- Continuous Renal NIRS Monitoring, Standard Clinical Care, Satisfaction Survey
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Renal NIRS MonitoringDevice
Renal oxygenation data collected every 6 seconds
Standard Clinical CareDiagnostic test
q6 h BP, q6 h Pulse ox, Echo at 24-72h
Standard Clinical CareDiagnostic test
Renal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h
Satisfaction SurveyOther
Survey to assess which method of monitoring is preferred
| Study group | Role | What they receive |
|---|---|---|
| Caregiver + Low Risk neonates | Participants in the nursery who are expected to be lower risk for CoA Receives: Device: Continuous Renal NIRS Monitoring; Diagnostic Test: Standard Clinical Care; Other: Satisfaction Survey | |
| Caregiver + Medium to High Risk neonates | Participants in the NICU who are expected to be at a higher risk for CoA Receives: Diagnostic Test: Standard Clinical Care | |
| Nurses in the Newborn Nursery | Nurses who work at the Meriter Hospital, Inc. Newborn Nursery Receives: Other: Satisfaction Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time monitored
Amount of time continuously monitored will be calculated
Measured: Up to 2 weeks post-delivery, on average
Count of adverse and unexpected events
All adverse and unexpected events will be recorded
Measured: Up to 2 weeks post-delivery
Secondary outcomes (3)
Change in nursing satisfaction with renal NIRS monitoring
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.
Measured: Study start to one year later
Parent/caregiver satisfaction with renal NIRS monitoring
A subjective description of survey responses in addition to determining which method of monitoring is preferred: NIRS vs. Enhanced BP/Pulse ox checks
Measured: Up to 2 weeks post-delivery, on average
Renal oxygen trends
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)
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start19 Apr 2023
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coarctation of AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Foundation
- Responsible party
- Sponsor
- Investigators
- Matthew Harer, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842876
- Sponsor's protocol ID
- 2022-1710
- Other IDs
- SMPH\PEDIATRICS\NEONATO, Protocol Version 3/29/2024, A536757
- Status last verified
- Mar 2025
- First submitted
- 21 Apr 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh Y. Evaluation of a child with suspected congenital heart disease. Paediatrics and Child Health 2018, 28(12): 556-561
Levey A, Glickstein JS, Kleinman CS, Levasseur SM, Chen J, Gersony WM, Williams IA. The impact of prenatal diagnosis of complex congenital heart disease on neonatal outcomes. Pediatr Cardiol. 2010 Jul;31(5):587-97. doi: 10.1007/s00246-010-9648-2. Epub 2010 Feb 18.
PubMed 20165844Gomez-Montes E, Herraiz Garcia I, Escribano Abad D, Rodriguez Calvo J, Villalain Gonzalez C, Galindo Izquierdo A. Application of a Global Multiparameter Scoring System for the Prenatal Prediction of Coarctation of the Aorta. J Clin Med. 2021 Aug 20;10(16):3690. doi: 10.3390/jcm10163690.
PubMed 34441986Maskatia SA, Kwiatkowski D, Bhombal S, Davis AS, McElhinney DB, Tacy TA, Algaze C, Blumenfeld Y, Quirin A, Punn R. A Fetal Risk Stratification Pathway for Neonatal Aortic Coarctation Reduces Medical Exposure. J Pediatr. 2021 Oct;237:102-108.e3. doi: 10.1016/j.jpeds.2021.06.047. Epub 2021 Jun 26.
PubMed 34181988Korcek P, Stranak Z, Sirc J, Naulaers G. The role of near-infrared spectroscopy monitoring in preterm infants. J Perinatol. 2017 Oct;37(10):1070-1077. doi: 10.1038/jp.2017.60. Epub 2017 May 4.
PubMed 28471443Hazle MA, Gajarski RJ, Aiyagari R, Yu S, Abraham A, Donohue J, Blatt NB. Urinary biomarkers and renal near-infrared spectroscopy predict intensive care unit outcomes after cardiac surgery in infants younger than 6 months of age. J Thorac Cardiovasc Surg. 2013 Oct;146(4):861-867.e1. doi: 10.1016/j.jtcvs.2012.12.012. Epub 2013 Jan 12.
PubMed 23317940
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal NIRS Monitoring to Detect Coarctation of the Aorta - A Pilot Study
- ClinicalTrials.gov ID
- NCT05842876
- Acronym / sponsor ID
- 2022-1710
- Conditions
- Coarctation of Aorta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Foundation
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caregiver + Low Risk neonates | – | Device: Continuous Renal NIRS Monitoring, Diagnostic Test: Standard Clinical Care, Other: Satisfaction SurveyParticipants in the nursery who are expected to be lower risk for CoA |
| Caregiver + Medium to High Risk neonates | – | Diagnostic Test: Standard Clinical CareParticipants in the NICU who are expected to be at a higher risk for CoA |
| Nurses in the Newborn Nursery | – | Other: Satisfaction SurveyNurses who work at the Meriter Hospital, Inc. Newborn Nursery |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Renal NIRS MonitoringRenal oxygenation data collected every 6 seconds | Device | Caregiver + Low Risk neonates |
| Standard Clinical Careq6 h BP, q6 h Pulse ox, Echo at 24-72h | Diagnostic test | Caregiver + Low Risk neonates |
| Standard Clinical CareRenal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h | Diagnostic test | Caregiver + Medium to High Risk neonates |
| Satisfaction SurveySurvey to assess which method of monitoring is preferred | Other | Caregiver + Low Risk neonates, Nurses in the Newborn Nursery |
Primary outcome
Percent of time monitored
Time frame: Up to 2 weeks post-delivery, on average
Amount of time continuously monitored will be calculated
Count of adverse and unexpected events
Time frame: Up to 2 weeks post-delivery
All adverse and unexpected events will be recorded
3 secondary outcomes
Change in nursing satisfaction with renal NIRS monitoring
Time frame: Study start to one year later
Parent/caregiver satisfaction with renal NIRS monitoring
Time frame: Up to 2 weeks post-delivery, on average
Renal oxygen trends
Time frame: Through study completion, approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- BackgroundSingh Y. Evaluation of a child with suspected congenital heart disease. Paediatrics and Child Health 2018, 28(12): 556-561
- Background: PubMed 20165844Levey A, Glickstein JS, Kleinman CS, Levasseur SM, Chen J, Gersony WM, Williams IA. The impact of prenatal diagnosis of complex congenital heart disease on neonatal outcomes. Pediatr Cardiol. 2010 Jul;31(5):587-97. doi: 10.1007/s00246-010-9648-2. Epub 2010 Feb 18.
- Background: PubMed 34441986Gomez-Montes E, Herraiz Garcia I, Escribano Abad D, Rodriguez Calvo J, Villalain Gonzalez C, Galindo Izquierdo A. Application of a Global Multiparameter Scoring System for the Prenatal Prediction of Coarctation of the Aorta. J Clin Med. 2021 Aug 20;10(16):3690. doi: 10.3390/jcm10163690.
- Background: PubMed 34181988Maskatia SA, Kwiatkowski D, Bhombal S, Davis AS, McElhinney DB, Tacy TA, Algaze C, Blumenfeld Y, Quirin A, Punn R. A Fetal Risk Stratification Pathway for Neonatal Aortic Coarctation Reduces Medical Exposure. J Pediatr. 2021 Oct;237:102-108.e3. doi: 10.1016/j.jpeds.2021.06.047. Epub 2021 Jun 26.
- Background: PubMed 28471443Korcek P, Stranak Z, Sirc J, Naulaers G. The role of near-infrared spectroscopy monitoring in preterm infants. J Perinatol. 2017 Oct;37(10):1070-1077. doi: 10.1038/jp.2017.60. Epub 2017 May 4.
- Background: PubMed 23317940Hazle MA, Gajarski RJ, Aiyagari R, Yu S, Abraham A, Donohue J, Blatt NB. Urinary biomarkers and renal near-infrared spectroscopy predict intensive care unit outcomes after cardiac surgery in infants younger than 6 months of age. J Thorac Cardiovasc Surg. 2013 Oct;146(4):861-867.e1. doi: 10.1016/j.jtcvs.2012.12.012. Epub 2013 Jan 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Harer, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coarctation of Aorta, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of time monitored (time frame: Up to 2 weeks post-delivery, on average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842876, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.