Bronchopulmonary DysplasiaNCT01644981
Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by University of Zurich at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 2 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- blood sampling
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants born before 32 weeks gestational age
Who may be able to join
- Very preterm infants born before 32 weeks gestational age
Who cannot join
- Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neonatology
Zurich, Canton of Zurich, 8091
About this study
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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- blood sampling
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood sampling
| Study group | Role | What they receive |
|---|---|---|
| VLBW infants | Not described Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of supplemental oxygen requirement
Bronchopulmonary dysplasia
Measured: 36 weeks postmenstrual age
Secondary outcomes (1)
duration of respiratory pressure support
respiratory pressure support either mechanical and/or nCPAP (days)
Measured: during hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Sven Wellmann, MD, Principal investigator, University Hospital Zurich, Division of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644981
- Sponsor's protocol ID
- 1.3 07.10.2011
- Status last verified
- May 2016
- First submitted
- 17 Jul 2012
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT01644981
- Acronym / sponsor ID
- 1.3 07.10.2011
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VLBW infants | – | Other: blood sampling |
Who may qualify
- Ages
- 2 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants born before 32 weeks gestational age
Key inclusion criteria (1 listed)
- Very preterm infants born before 32 weeks gestational age
Key exclusion criteria (1 listed)
- Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling | Other | VLBW infants |
Primary outcome
duration of supplemental oxygen requirement
Time frame: 36 weeks postmenstrual age
Bronchopulmonary dysplasia
1 secondary outcome
duration of respiratory pressure support
Time frame: during hospitalisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchopulmonary Dysplasia
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Recruiting
Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Wellmann, MD principal investigator
University Hospital Zurich, Division of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of supplemental oxygen requirement (time frame: 36 weeks postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.