Congenital Heart Disease Clinical Trial
Official title:
Cardiac Biomarkers in Patients With Single Ventricle Physiology
NCT number | NCT03678909 |
Other study ID # | H-42776 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | July 30, 2020 |
Verified date | July 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Mortality up to anticipated Glenn Procedure | 3- 6 months depending on second stage procedure | |
Secondary | NEC | Incidence of Necrotizing enterocolitis | 3- 6 months depending on second stage procedure | |
Secondary | Reintubation | Incidence of Reintubation | 3- 6 months depending on second stage procedure | |
Secondary | Cath intervention | Incidence of cath interventions | 3- 6 months depending on second stage procedure |
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