NCT01644981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

July 17, 2012

Last Update Submit

May 9, 2016

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • duration of supplemental oxygen requirement

    Bronchopulmonary dysplasia

    36 weeks postmenstrual age

Secondary Outcomes (1)

  • duration of respiratory pressure support

    during hospitalisation

Study Arms (1)

VLBW infants

Other: blood sampling

Interventions

blood samplingOTHER

blood sampling

VLBW infants

Eligibility Criteria

Age2 Weeks - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

infants born before 32 weeks gestational age

You may qualify if:

  • Very preterm infants born before 32 weeks gestational age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Neonatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sven Wellmann, MD

    University Hospital Zurich, Division of Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

CH(1)