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N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life

This study has been withdrawn prior to enrollment.
(Did not receive budget needed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425581
First Posted: January 23, 2007
Last Update Posted: January 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants. We would also evaluate the hypothesis that there is an association between the level of these proteins in the serum and the short and long term morbidity.

Condition
Hypotension Very Low Birth Weight Infants Ventricular Dysfunction Prematurity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: N-Terminal Pro-B-Type and Cardiac Troponin T Levels for Monitoring Effectiveness of Treatment in Very Low Birth Weight Infants With Hemodynamic Instability

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 100
Study Start Date: February 2007
Detailed Description:
NT-proBNP is a member of the natriuretic hormone family which plays an important role in regulation of extracellular fluid volume and blood pressure.It is secreted from the cardiac ventricle myocytes in response to myocardial stress. This hormone serves as a marker of ventricular dysfunction in adults but its role in newborns and especially preterm infants has not been well studied yet. Following birth of a healthy infant there is a surge in NT-proBNP levels which is then followed by a rapid decrease. One explanation for this surge is the transition in hemodynamics from fetal circulation into postnatal one. Few studies conducted in this area have shown association between NT-proBNP level and patency of ductus arteriosus and with respiratory distress syndrome of the newborn. Cardiac troponin T (cTnT)is a specific cardiac protein which serves as a specific indicator of cardiac damage in adults, it is usually not detected at birth but following myocardial injury its serum levels will slowly rise and generally will not be detectable until at least 4 hours after onset of injury. There is no "gold standard" test for diagnosis of hemodynamic instability in very low birth weight infants. Myocardial dysfunction is thought to be the major cause for this condition in VLBW population. Since this condition is associated with severe short and long term morbidity early recognition and specific treatment may be detrimental. We hypothesized that NT-proBNP and cTnT levels may serve as a more accurate markers for diagnosis, monitoring, and outcome prediction in VLBW infants during the first days of life, than the methods we currently use (blood pressure, urine output etc.)
  Eligibility

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VLBW infants born at Sheba medical Center

Exclusion Criteria:

  • known cardiac or chromosomal anomaly
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425581


Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Morag, MD Sheba Medical Center
  More Information

Publications:
Responsible Party: Dr. Iris Morag, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00425581     History of Changes
Other Study ID Numbers: SHEBA-06-4255-IM-CTIL
First Submitted: January 22, 2007
First Posted: January 23, 2007
Last Update Posted: January 24, 2008
Last Verified: January 2008

Keywords provided by Sheba Medical Center:
N-terminal pro-BNP,
Cardiac Troponin-T,
Very low birth weight infants
hemodynamic instability
myocardial dysfunction

Additional relevant MeSH terms:
Body Weight
Hypotension
Birth Weight
Ventricular Dysfunction
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs