Prospective Study on Plasma Pro-endothelin-1 in Predictin... | NCT01644981

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

NCT01644981

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 10, 2016Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Bronchopulmonary Dysplasia

Interventions

blood sampling

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 17, 2012

First Submission Date that Met QC Criteria

Jul 18, 2012

First Posted Date

Jul 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2016

Last Update Posted Date

May 10, 2016Estimated

Name	Class
University Children's Hospital Basel	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Actual

Label	Type	Description	Intervention Names
VLBW infants			Other: blood sampling

Name	Type	Description	Arm Group Labels	Other Names
blood sampling	Other	blood sampling	VLBW infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of supplemental oxygen requirement	Bronchopulmonary dysplasia	36 weeks postmenstrual age

Secondary Outcomes

Measure	Description	Time Frame
duration of respiratory pressure support	respiratory pressure support either mechanical and/or nCPAP (days)	during hospitalisation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

4 Months

Standard Ages

Child

Study Population

infants born before 32 weeks gestational age

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven Wellmann, MD	University Hospital Zurich, Division of Neonatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Neonatology		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001997	Bronchopulmonary Dysplasia

Ancestor Terms

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided