Happy Baby Hearts Study

Coarctation of Aorta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842876
• Other study ID #: 2022-1710
• Secondary ID: SMPH\PEDIATRICS\
• Status: Recruiting
• Start date: April 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Meg Baker
• Phone: 608-263-7125
• Email: meg.baker[@]wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of Aorta

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Meriter Hospital, Inc.	Madison	Wisconsin
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Meriter Foundation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of time monitored	Amount of time continuously monitored will be calculated	Up to 2 weeks post-delivery, on average
Primary	Count of adverse and unexpected events	All adverse and unexpected events will be recorded	Up to 2 weeks post-delivery
Secondary	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.	Study start to one year later
Secondary	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	Up to 2 weeks post-delivery, on average
Secondary	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)	Through study completion, approximately 1 year