Happy Baby Hearts Study

NCT05842876 | Completed DMC FDA Device

• 4 other identifiers: 2022-1710SMPH\PEDIATRICS\NEONATOProtocol Version 3/29/2024A536757
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Percent of time monitored

  Amount of time continuously monitored will be calculated

  Up to 2 weeks post-delivery, on average

• Count of adverse and unexpected events

  All adverse and unexpected events will be recorded

  Up to 2 weeks post-delivery

Secondary Outcomes (3)

• Change in nursing satisfaction with renal NIRS monitoring

  Study start to one year later

• Parent/caregiver satisfaction with renal NIRS monitoring

  Up to 2 weeks post-delivery, on average

• Renal oxygen trends

  Through study completion, approximately 1 year

Study Arms (3)

Caregiver + Low Risk neonates

Participants in the nursery who are expected to be lower risk for CoA

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

Diagnostic Test: Standard Clinical Care

Nurses in the Newborn Nursery

Nurses who work at the Meriter Hospital, Inc. Newborn Nursery

Other: Satisfaction Survey

Interventions

Continuous Renal NIRS Monitoring DEVICE

Renal oxygenation data collected every 6 seconds

Caregiver + Low Risk neonates

Standard Clinical Care DIAGNOSTIC_TEST

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

Caregiver + Low Risk neonates

Satisfaction Survey OTHER

Survey to assess which method of monitoring is preferred

Caregiver + Low Risk neonates; Nurses in the Newborn Nursery

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Meriter Foundation: collaborator

Study Sites (2)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Meriter Hospital, Inc.

Madison, Wisconsin, 53715, United States

Location

Related Publications (6)

• Singh Y. Evaluation of a child with suspected congenital heart disease. Paediatrics and Child Health 2018, 28(12): 556-561

  BACKGROUND

• 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.

  PMID: 20165844 BACKGROUND

• Gomez-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.

  PMID: 34441986 BACKGROUND

• Maskatia 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.

  PMID: 34181988 BACKGROUND

• Korcek 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.

  PMID: 28471443 BACKGROUND

• Hazle 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.

  PMID: 23317940 BACKGROUND

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthew Harer, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: April 19, 2023
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)