NCT00528736

Brief Summary

The aim of the study was to evaluate BNP in preterm infants \< 28 weeks on the second day of life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the need of PDA intervention in the further course.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

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, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
Last Updated

September 14, 2007

Status Verified

September 1, 2007

First QC Date

September 10, 2007

Last Update Submit

September 12, 2007

Conditions

Infant, PrematureDuctus Arteriosus, PatentNatriuretic Peptide Brain

Keywords

preterm infants < 28 weeksB-type natriuretic peptidepredictionductus intervention

Eligibility Criteria

Age24 Hours - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Written parental informed consent
  • Preterm infant \< 28 weeks of gestation
  • 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)

Department of Neonatology, Charite Virchow Hospital, Medical University Berlin

Berlin, State of Berlin, 13353, Germany

Location

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

    Department of Neonatology, Charite Virchow Hospital, Medical University Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

August 1, 2005

Study Completion

April 1, 2007

Last Updated

September 14, 2007

Record last verified: 2007-09

Locations

DE(1)