Clinical trial NCT05842876: Happy Baby Hearts Study
Official title: Renal NIRS Monitoring to Detect Coarctation of the Aorta - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coarctation of Aorta
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Meriter Foundation
First posted: 2023-05-06
Enrollment: 82
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent of time monitored
timeFrame: Up to 2 weeks post-delivery, on average
measure: Count of adverse and unexpected events
timeFrame: Up to 2 weeks post-delivery
Secondary outcomes:
measure: Change in nursing satisfaction with renal NIRS monitoring
timeFrame: Study start to one year later
measure: Parent/caregiver satisfaction with renal NIRS monitoring
timeFrame: Up to 2 weeks post-delivery, on average
measure: Renal oxygen trends
timeFrame: Through study completion, approximately 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Madison
country: United States
facility: Meriter Hospital, Inc.
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Matthew Harer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh Y. Evaluation of a child with suspected congenital heart disease. Paediatrics and Child Health 2018, 28(12): 556-561
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.