Congenital DisordersNCT00327782
Palliative Care of Children With End-Stage Heart Failure
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Palliative care in pediatric oncology and neurology is well described in the literature. There is a lack of information on the care of children terminally ill due to heart failure. A significant number of children are diagnosed with terminal heart failure for which palliative care is required. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Congenital Disorders
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 1995to Apr 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any patient between 1 - 18 years of age (inclusive) Any patient with end stage heart disease Treated at Egleston Hospital, Children's Healthcare of Atlanta Followed by Sibley Heart Center Cardiology
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Palliative care in pediatric oncology and neurology is well described in the literature. There is a lack of information on the care of children terminally ill due to heart failure. A significant number of children are diagnosed with terminal heart failure for which palliative care is required.
Objective:
To describe palliative care of children over one year of age with end-stage heart failure, including need for and types of pain control, hospice use, need for and use of home nursing and quality of life issues.
Read the detailed description
Methods:
Retrospective chart review of all children over one year of age diagnosed with end-stage heart failure between January 1, 1995 and December 31, 2005 at Children's Healthcare of Atlanta, Egleston Hospital, followed by Sibley Heart Center Cardiology.
Patient variables taken from the medical charts will include:
Diagnosis Age, gender Medications Prior surgery or transplantation Associated conditions such as muscular dystrophy, renal failure
Practice variables taken from the medical charts will include:
Hospice care provided Home inotropic infusions Medications administered for pain Social work/psychology evaluation DNR status
Statistics:
Number of patients receiving home nursing, involved in hospice, treated with pain medications, home oxygen or home inotropes.
- Conditions
- Congenital Disorders
- Keywords
- pediatric, palliative care, end stage heart failure
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startJan 1995
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- William T Mahle, MD, Principal investigator, Emory University SOM, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327782
- Sponsor's protocol ID
- 06-114
- Status last verified
- May 2007
- First submitted
- 18 May 2006
- Last updated
- 4 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care of Children With End-Stage Heart Failure
- ClinicalTrials.gov ID
- NCT00327782
- Acronym / sponsor ID
- 06-114
- Conditions
- Congenital Disorders
- Keywords
- pediatric, palliative care, end stage heart failure
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 1995
- Study completion
- Apr 2006
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palliative care in pediatric oncology and neurology is well described in the literature. There is a lack of information on the care of children terminally ill due to heart failure. A significant number of children are diagnosed with terminal heart failure for which palliative care is required.
Objective:
To describe palliative care of children over one year of age with end-stage heart failure, including need for and types of pain control, hospice use, need for and use of home nursing and quality of life issues.
Detailed description
Methods:
Retrospective chart review of all children over one year of age diagnosed with end-stage heart failure between January 1, 1995 and December 31, 2005 at Children's Healthcare of Atlanta, Egleston Hospital, followed by Sibley Heart Center Cardiology.
Patient variables taken from the medical charts will include:
Diagnosis Age, gender Medications Prior surgery or transplantation Associated conditions such as muscular dystrophy, renal failure
Practice variables taken from the medical charts will include:
Hospice care provided Home inotropic infusions Medications administered for pain Social work/psychology evaluation DNR status
Statistics:
Number of patients receiving home nursing, involved in hospice, treated with pain medications, home oxygen or home inotropes.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Any patient between 1 - 18 years of age (inclusive) Any patient with end stage heart disease Treated at Egleston Hospital, Children's Healthcare of Atlanta Followed by Sibley Heart Center Cardiology
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Mahle, MD principal investigator
Emory University SOM, Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2007.