Clinical trial NCT00425581: 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
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypotension
Very Low Birth Weight Infants
Ventricular Dysfunction
Prematurity
Keywords: N-terminal pro-BNP,
Cardiac Troponin-T,
Very low birth weight infants
hemodynamic instability
myocardial dysfunction
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 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.

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 criteria: Inclusion Criteria:

* VLBW infants born at Sheba medical Center

Exclusion Criteria:

* known cardiac or chromosomal anomaly

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Iris Morag, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bar-Oz B, Lev-Sagie A, Arad I, Salpeter L, Nir A. N-terminal pro-B-type natriuretic peptide concentrations in mothers just before delivery, in cord blood, and in newborns. Clin Chem. 2005 May;51(5):926-7. doi: 10.1373/clinchem.2005.048892. No abstract available.
citation: Nasser N, Bar-Oz B, Nir A. Natriuretic peptides and heart disease in infants and children. J Pediatr. 2005 Aug;147(2):248-53. doi: 10.1016/j.jpeds.2005.03.051. No abstract available.
citation: Makikallio K, Vuolteenaho O, Jouppila P, Rasanen J. Ultrasonographic and biochemical markers of human fetal cardiac dysfunction in placental insufficiency. Circulation. 2002 Apr 30;105(17):2058-63. doi: 10.1161/01.cir.0000015505.24187.fa.
citation: Cowie MR, Mendez GF. BNP and congestive heart failure. Prog Cardiovasc Dis. 2002 Jan-Feb;44(4):293-321. doi: 10.1053/pcad.2002.24599.
citation: Puddy VF, Amirmansour C, Williams AF, Singer DR. Plasma brain natriuretic peptide as a predictor of haemodynamically significant patent ductus arteriosus in preterm infants. Clin Sci (Lond). 2002 Jul;103(1):75-7. doi: 10.1042/cs1030075.