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Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01644981
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : May 10, 2016
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date July 17, 2012
First Posted Date July 19, 2012
Last Update Posted Date May 10, 2016
Study Start Date May 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2016)
duration of supplemental oxygen requirement [ Time Frame: 36 weeks postmenstrual age ]
Bronchopulmonary dysplasia
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: February 24, 2014)
duration of respiratory pressure support [ Time Frame: during hospitalisation ]
respiratory pressure support either mechanical and/or nCPAP (days)
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
Official Title Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
Brief Summary Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker of BPD.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
EDTA plasma
Sampling Method Probability Sample
Study Population infants born before 32 weeks gestational age
Condition Bronchopulmonary Dysplasia
Intervention Other: blood sampling
blood sampling
Study Groups/Cohorts VLBW infants
Intervention: Other: blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2014)
110
Original Estimated Enrollment
 (submitted: July 18, 2012)
100
Actual Study Completion Date December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Very preterm infants born before 32 weeks gestational age

Exclusion criteria:

  • Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops
Sex/Gender
Sexes Eligible for Study: All
Ages up to 4 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01644981
Other Study ID Numbers 1.3 07.10.2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators University Children's Hospital Basel
Investigators
Principal Investigator: Sven Wellmann, MD University Hospital Zurich, Division of Neonatology
PRS Account University of Zurich
Verification Date May 2016