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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00425581
First received: January 22, 2007
Last updated: January 22, 2008
Last verified: January 2008
  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

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VLBW infants born at Sheba medical Center

Exclusion Criteria:

  • known cardiac or chromosomal anomaly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 22, 2007
Last Updated: January 22, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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:
Birth Weight
Body Weight
Hypotension
Ventricular Dysfunction
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014