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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644981
First Posted: July 19, 2012
Last Update Posted: May 10, 2016
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.
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention
Bronchopulmonary Dysplasia Other: blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • duration of supplemental oxygen requirement [ Time Frame: 36 weeks postmenstrual age ]
    Bronchopulmonary dysplasia


Secondary Outcome Measures:
  • duration of respiratory pressure support [ Time Frame: during hospitalisation ]
    respiratory pressure support either mechanical and/or nCPAP (days)


Biospecimen Retention:   Samples Without DNA
EDTA plasma

Enrollment: 110
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
VLBW infants Other: blood sampling
blood sampling

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
infants born before 32 weeks gestational age
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644981


Locations
Switzerland
University Hospital Zurich, Division of Neonatology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
University Children's Hospital Basel
Investigators
Principal Investigator: Sven Wellmann, MD University Hospital Zurich, Division of Neonatology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01644981     History of Changes
Other Study ID Numbers: 1.3 07.10.2011
First Submitted: July 17, 2012
First Posted: July 19, 2012
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases