Bronchopulmonary DysplasiaPhase 3ClaprumNCT01652118
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis
A Phase 3 study testing clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia and Saline in people with Bronchopulmonary Dysplasia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies. Read more about this study
- Who is it for?
- Ages 1 hour to 2 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2011to Jan 2013
- Phase
- Phase 3
- 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 1 hour to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all infant must be under 1250 gram birth weight
Who cannot join
- Major congenital anomaly,
- CardiaC abnormality,
- without inform consent
Trial locations and contacts
1 site in 1 country.
Fuat Emre Canpolat, M.D. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Middle Anatolia, 06600
Sadık Yurttutan, M.D, 0905059079727
Fuat Emre Canpolat, M.D., femrecan@gmail.com
About this study
Official title: Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.
Read the detailed description
The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.
The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia, Saline
- Keywords
- bronchopulmonary dysplasia, clarithromycin, preterm babies
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin treatment for prophylaxis of bronchopulmonary dysplasiaDrug
Also called Claprum
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin | Active comparator | Fist group treated with clarithromycin which is include 10 days application. Receives: Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia |
| placebo | Placebo comparator | Second group treated with salin as same as amount of clarithromycine volume Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia
Measured: 28. day of birth
Secondary outcomes (1)
Overall survival
During to hospitalisation the investigator will determine and record some co-morbidities of BPD such as intracranial hemorrhage, necrotizing enterocolitis, patent ductus arteriosus rates.From date of randomization until the end of the hospitalisation up to the 3 months of life.
Measured: Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadik Yurttutan, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Ugur Dilmen, Prof. Dr., Study director, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652118
- Sponsor's protocol ID
- 05059079727
- Acronym
- Claprum
- Status last verified
- Jul 2012
- First submitted
- 22 Jul 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
- ClinicalTrials.gov ID
- NCT01652118
- Acronym / sponsor ID
- Claprum / 05059079727
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- bronchopulmonary dysplasia, clarithromycin, preterm babies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 27 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.
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.
Detailed description
The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.
The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin | Active comparator | Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasiaFist group treated with clarithromycin which is include 10 days application. |
| placebo | Placebo comparator | Drug: SalineSecond group treated with salin as same as amount of clarithromycine volume |
Who may qualify
- Ages
- 1 hour to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all infant must be under 1250 gram birth weight
Key exclusion criteria (3 listed)
- Major congenital anomaly,
- CardiaC abnormality,
- without inform consent
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 |
|---|---|---|
| clarithromycin treatment for prophylaxis of bronchopulmonary dysplasiaAlso: Claprum | Drug | Clarithromycin |
| Saline | Drug | placebo |
Primary outcome
Bronchopulmonary dysplasia
Time frame: 28. day of birth
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia
1 secondary outcome
Overall survival
Time frame: Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Fuat Emre Canpolat, M.D. contact
Ugur Dilmen, Prof. Dr. study director
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia and Saline in people with Bronchopulmonary Dysplasia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2012. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sadık Yurttutan, M.D (0905059079727, sdkyurttutan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia (time frame: 28. day of birth). 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 27 Jul 2012.