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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 25, 2014