NCT00799123

Brief Summary

The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically significant ductus arteriosus. The investigators also hypothesized that new echocardiographic parameters such as isovolumic relaxation time (IVRT)is useful for the prediction of ductus intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 12, 2010

Status Verified

April 1, 2010

Enrollment Period

1.3 years

First QC Date

November 26, 2008

Last Update Submit

April 9, 2010

Conditions

Infant, PrematureDuctus Arteriosus, PatentVentricular Function, Left

Keywords

NT-proBNP

Eligibility Criteria

Age24 Hours - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

VLBW infants

You may qualify if:

  • Written parental informed consent
  • VLBW infants
  • Admitted to our NICU within 48 hours after birth

You may not qualify if:

  • No written parental informed consent
  • Congenital heart disease
  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite, Medical University

Berlin, State of Berlin, 13353, Germany

Location

Biospecimen

urine

MeSH Terms

Conditions

Premature BirthDuctus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christoph Czernik, MD

    Charite, Medical University Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 12, 2010

Record last verified: 2010-04

Locations

DE(1)