NCT00425581

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.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

First QC Date

January 22, 2007

Last Update Submit

January 22, 2008

Conditions

HypotensionVery Low Birth Weight InfantsVentricular DysfunctionPrematurity

Keywords

N-terminal pro-BNP,Cardiac Troponin-T,Very low birth weight infantshemodynamic instabilitymyocardial dysfunction

Eligibility Criteria

Age1 Minute - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • VLBW infants born at Sheba medical Center

You may not qualify if:

  • known cardiac or chromosomal anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 15855678BACKGROUND

  • 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.

    PMID: 16126059BACKGROUND

  • 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.

    PMID: 11980685BACKGROUND

  • 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.

    PMID: 12007084BACKGROUND

  • 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.

    PMID: 12095406BACKGROUND

MeSH Terms

Conditions

HypotensionVentricular DysfunctionPremature BirthCardiomyopathy, Familial Restrictive, 3

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Iris Morag, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

February 1, 2007

Last Updated

January 24, 2008

Record last verified: 2008-01