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OpenTrials
Completed

NCT Number: NCT03678909

Cardiac Biomarkers in Patients With Single Ventricle Physiology

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.

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Key information

Conditions

Hypoplastic Left Heart Cardiac Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cyanotic Congenital Heart Disease Heart Defects, Congenital Heart Diseases Hypoplastic Left Heart Syndrome

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Procedure

Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Primary outcomes

  1. Mortality

    Time frame: 3- 6 months depending on second stage procedure

    Mortality up to anticipated Glenn Procedure

Secondary outcomes

  1. NEC

    Time frame: 3- 6 months depending on second stage procedure

    Incidence of Necrotizing enterocolitis

  2. Reintubation

    Time frame: 3- 6 months depending on second stage procedure

    Incidence of Reintubation

  3. Cath intervention

    Time frame: 3- 6 months depending on second stage procedure

    Incidence of cath interventions

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2018
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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