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

This study has been completed.
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01644981
First received: July 17, 2012
Last updated: February 24, 2014
Last verified: February 2014
  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

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 ] [ Designated as safety issue: No ]
    Bronchopulmonary dyspalsia


Secondary Outcome Measures:
  • duration of respiratory pressure support [ Time Frame: during hospitalisation ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

VLBW infants

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01644981     History of Changes
Other Study ID Numbers: 1.3 07.10.2011
Study First Received: July 17, 2012
Last Updated: February 24, 2014
Health Authority: Switzerland: UZurich

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

ClinicalTrials.gov processed this record on April 22, 2014