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Heart DiseasesNCT00330811

B-type Natriuretic Peptide in the Non-Cardiac Pediatric Patient

An observational study of Heart Diseases, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

B-type Natriuretic Peptide (BNP) is a hormone that is made by the pumping chambers of the heart. The BNP level can be measured by a blood test and is used as a marker for heart problems in adults. Deciding if a child has a heart problem or a lung problem can be very difficult, especially in infants. Read more about this study

Who is it for?
Ages 1 day to 5 years
Conditions the study is for
Heart Diseases
How many people
87 participants
Where
1 siteUnited States
Study dates
Apr 2006to May 2007
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 day to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Any child who is less than 6 years old seen in the Emergency Department evaluated for respiratory and/or infectious disease with order/s to have blood draw.

Who may be able to join

  • Any child presenting to the pediatric ED at Children's Healthcare of Atlanta (CHOA)at Egleston undergoing evaluation for respiratory and/or infectious disease.
  • Patient age is less than 6 years old.
  • Patients having venipuncture for lab studies as a part of the ED admission.
  • Informed consent being obtained from the legal guardians.

Who cannot join

  • Patients with known congenital or acquired heart disease.
  • Patients with previously diagnosed systemic disease such as malignancy, HIV, cystic fibrosis, organ transplant recipients.
  • Patients that will not be having venipuncture for lab studies as a part of the ED admission.
  • Trauma patients or those presenting with broken bones, dog bites, etc. (non-infectious presentation.)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

Other trials in United States

About this study

B-type Natriuretic Peptide (BNP) is a hormone that is made by the pumping chambers of the heart. The BNP level can be measured by a blood test and is used as a marker for heart problems in adults. Deciding if a child has a heart problem or a lung problem can be very difficult, especially in infants. Several studies have demonstrated that BNP levels are elevated when children have heart disease.

The overall goal of the study is to be able to prove that obtaining BNP levels in pediatric patients can be used to identify heart problems. We already know that kids with heart problems have high BNP levels (>200pg/ml). We need to prove that children who come to the Emergency Department for non-cardiac problems still have normal BNP levels (<100pg/ml, slightly higher in the newborn population). This will be done by comparing BNP levels with the final diagnosis made by the ED physician.

Read the detailed description

Introduction At Children's Healthcare of Atlanta, thousands of children are seen in the Emergency Department (ED) each year for evaluation and treatment. Deciding if a child has a cardiac or pulmonary problem can be very difficult, especially in infants. Early recognition of cardiac disease can significantly impact the physician's ability to provide appropriate treatment, make necessary interventions, and affect patient outcome. An accurate laboratory marker of cardiac disease for pediatric Emergency Medicine does not exist. B-Type Natriuretic Peptide (BNP) is a hormone produced by the ventricular myocardium (heart muscle) in response to increased myocardial demands. It has been used extensively in the adult population to evaluate patients for heart disease, and has been demonstrated to be very accurate in the differentiation of heart disease from lung disease in the adult Emergency Department.

There is increasing experience with BNP in pediatrics for the evaluation of heart disease, primarily in patients with congenital heart disease. The normal BNP level is less than 100 pg/ml, slightly higher in neonates. Patients who present to the ED and are diagnosed with heart disease are often admitted to the Cardiac Intensive Care Unit (CICU) for further management and stabilization. Part of the initial evaluation is a BNP level. These patients usually have marked elevation of the BNP levels in the 2000-5000 pg/ml range upon admission. The level varies with the type and severity of their heart disease. However very little is known about the non-cardiac ED patient BNP level. To utilize BNP as an accurate marker of cardiac disease in the pediatric ED, a clear difference between cardiac and non-cardiac patients needs to be demonstrated. If a large difference in BNP levels exists for the pediatric patient with heart disease who presents to the ED when compared to the child who presents to the ED with other non-cardiac disease processes, a useful marker of heart disease in children would be demonstrated.

Objectives: The objective of the proposed research is to determine the typical BNP level in non-cardiac pediatric patients who present to the ED for evaluation of respiratory and/ or infectious processes. The endpoint of the project will be the collection of BNP levels from 100 patients less than 6 years of age.

Hypothesis 1 (H1): BNP levels for children with non-cardiac disease will be in the normal range (< 100pg/ml), and can be easily distinguished from the elevated levels seen in children with congenital or acquired heart disease.

Conditions
Heart Diseases
Keywords
Pediatrics, Non-cardiac Illness, B-type Natriuretic Peptide (BNP)
Medical subject headings
Heart Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionJan 2007
  4. Study completionMay 2007

Resources

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
Cohort
Time perspective
Prospective
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00330811
Sponsor's protocol ID
1409-2005
Status last verified
Nov 2016
First submitted
25 May 2006
Last updated
2 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Diseases, run by Emory University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 2 Dec 2016.

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