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NCT00268060 Clinical Trial

Infant Medical Records: Case Report Proposal

Congenital Disorders Clinical Trial

Official title:
Baby R. Case Report Proposal

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00268060
Other study ID # 05-050
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2005
Last updated May 3, 2007
Start date September 2004

Study information
Verified date May 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have been recognized as a clinical subset of children with LQTS.

The purpose of this study is to describe the clinical course and outcome of a patient with congenital long QT syndrome (LQTS).

Description:

It has been previously reported that 2:1 AVB in neonatal LQTS seems preferentially associated with HERG mutations . It has also been reported in association with the SCN5A gene. We report on a neonate with congenital LQTS and congenital complete heart block who experienced frequent episodes of torades des pointe and ventricular tachycardia, which, over the first 2 days of life, was recalcitrant to traditional therapy of beta-blockers and other antiarrhythmics. Eventually hypotension necessitated the use of an epinephrine infusion, which halted the ventricular tachyarrhythmias. A pacemaker was implanted once the infant was stable and, currently, he is thriving. Genetic analysis revealed a HERG mutation.

For this study, we will need access to the infant’s inpatient and outpatient medical records at Children's Healthcare of Atlanta at Egleston Children’s Hospital and Sibley Heart Center Cardiology to include his age, date of birth, medical record number, inpatient labs, inpatient echo reports, outpatient echo reports, inpatient and outpatient EKG’s, inpatient pharmacy records, the results of his genetic analysis, his history and physical, transfer notes, daily progress notes, consultation reports and operative reports from his admission beginning 9/30/04.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Congenital long QT Syndrome single case report

Exclusion Criteria:

- Single case report

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Chldren's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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