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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH\PEDIATRICS\NEONATO | Other Identifier | UW Madison | |
| Protocol Version 3/29/2024 | Other Identifier | UW Madison | |
| A536757 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Meriter Foundation | OTHER |
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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:
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiver + Low Risk neonates | Participants in the nursery who are expected to be lower risk for CoA |
| |
| Caregiver + Medium to High Risk neonates | Participants in the NICU who are expected to be at a higher risk for CoA |
| |
| Nurses in the Newborn Nursery | Nurses who work at the Meriter Hospital, Inc. Newborn Nursery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Renal NIRS Monitoring | Device | Renal oxygenation data collected every 6 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Neonate Inclusion Criteria:
Neonate Exclusion Criteria:
Primary Caregiver Inclusion Criteria:
Primary Caregiver Exclusion Criteria:
Newborn Nursery Nursing Staff:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Harer, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States | ||
| Meriter Hospital, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Singh Y. Evaluation of a child with suspected congenital heart disease. Paediatrics and Child Health 2018, 28(12): 556-561 | ||
| 20165844 | 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. | |
| 34441986 |
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| ID | Term |
|---|---|
| D001017 | Aortic Coarctation |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| Standard Clinical Care | Diagnostic Test | q6 h BP, q6 h Pulse ox, Echo at 24-72h |
|
| Standard Clinical Care | Diagnostic Test | Renal oxygenation data collected every 6 seconds, q6 h BP, continuous Pulse ox, Echo at 12-72h |
|
| Satisfaction Survey | Other | Survey to assess which method of monitoring is preferred |
|
| 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 |
| 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 |
| Madison |
| Wisconsin |
| 53715 |
| United States |
| 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. |
| 34181988 | 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. |
| 28471443 | 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. |
| 23317940 | 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. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |