NCT00330811

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

May 25, 2006

Last Update Submit

November 30, 2016

Conditions

Keywords

PediatricsNon-cardiac IllnessB-type Natriuretic Peptide (BNP)

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Kevin O Maher, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 29, 2006

Study Start

April 1, 2006

Primary Completion

January 1, 2007

Study Completion

May 1, 2007

Last Updated

December 2, 2016

Record last verified: 2016-11

Locations