Cardiac Biomarkers in Patients With Single Ventricle Physiology

Study Overview
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Brief Summary
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All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Detailed Description
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All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Official Title
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Cardiac Biomarkers in Patients With Single Ventricle Physiology

Conditions
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Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Cardiac Disease

Intervention / Treatment
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* Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate Exclusion Criteria: Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypoplastic Left Heart Disease<br>Patients with congenital hypoplastic left heart disease who will undergo surgical palliation with Norwood procedure or DKS or Damus-Kaye-Stansel procedure | Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure<br>* Norwood Palliation / DKS / Damus-Kaye-Stansel procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality up to anticipated Glenn Procedure | 3- 6 months depending on second stage procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEC | Incidence of Necrotizing enterocolitis | 3- 6 months depending on second stage procedure | 
| Reintubation | Incidence of Reintubation | 3- 6 months depending on second stage procedure | 
| Cath intervention | Incidence of cath interventions | 3- 6 months depending on second stage procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BNP, DKS, Troponin, Biomarkers, Hypoplastic Left Heart, Norwood