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Home Inotropic Therapy in Children
This study is ongoing, but not recruiting participants.
Sponsored by: Children's Healthcare of Atlanta
Information provided by: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00327899
  Purpose

Inotropic therapy is a well-established practice for children with advanced congestive heart failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and prolong life while awaiting heart transplantation. Traditionally children have been maintained on inotropic therapy in the hospital under close, monitored supervision. The United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed listing criteria allowing patients awaiting heart transplantation to be discharged to home, yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has been shown to be a safe and cost-effective bridge to transplantation. To date, there are no data on the use of home inotropic therapy in children.

Hypothesis:

We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.


Condition
Congenital Disorders

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title: Home Inotropic Therapy in Children

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 35
Detailed Description:

Hypothesis:

We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.

Methods:

Data will be obtained from CHOA and Coram Home Healthcare, Inc over a two year period, January 1, 2004 through December 31, 2005. Data will be collected on approximately 35 children aged 0-18 years receiving therapy. The length of therapy, type of therapy, therapy-related complications, number of readmissions, deaths at home and catheter-related infections data will be collected.

Inclusion Criteria:

Receiving inotropic support at home Choa patients with Coram Healthcare only

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving inotropic support at home
  • Choa patients with Coram Healthcare only
  • medical charts between 2.2.2004 and 12.31.2005

Exclusion Criteria:

  • those who do not meet inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327899

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Alexandria Berg, MSN Children's Healthcare of Atlanta
  More Information

Study ID Numbers: 06-129
Study First Received: May 18, 2006
Last Updated: May 18, 2006
ClinicalTrials.gov Identifier: NCT00327899  
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
pediatric
congestive heart failure
inotropes

Study placed in the following topic categories:
Heart Failure

ClinicalTrials.gov processed this record on January 14, 2009