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NCT01644981 Clinical Trial

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

Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01644981
Other study ID # 1.3 07.10.2011
Secondary ID
Status Completed
Phase N/A
First received July 17, 2012
Last updated May 9, 2016
Start date May 2012
Est. completion date December 2013

Study information
Verified date May 2016
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 4 Months
Eligibility Inclusion criteria:

- Very preterm infants born before 32 weeks gestational age

Exclusion criteria:

- Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• blood sampling
blood sampling

Locations
Country Name City State
Switzerland University Hospital Zurich, Division of Neonatology Zurich ZH

Sponsors (2)
Lead Sponsor Collaborator
University of Zurich University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary duration of supplemental oxygen requirement Bronchopulmonary dysplasia 36 weeks postmenstrual age No
Secondary duration of respiratory pressure support respiratory pressure support either mechanical and/or nCPAP (days) during hospitalisation No
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