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Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis (Claprum)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01652118
First Posted: July 27, 2012
Last Update Posted: July 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital
  Purpose
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.

Condition Intervention Phase
Bronchopulmonary Dysplasia Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia Drug: Saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin

Resource links provided by NLM:


Further study details as provided by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks ]
    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.


Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clarithromycin
Fist group treated with clarithromycin which is include 10 days application.
Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
Other Name: Claprum
Placebo Comparator: placebo
Second group treated with salin as same as amount of clarithromycine volume
Drug: Saline

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all infant must be under 1250 gram birth weight

Exclusion Criteria:

  • Major congenital anomaly,
  • CardiaC abnormality,
  • without inform consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652118


Contacts
Contact: Sadık Yurttutan, M.D 0905059079727 sdkyurttutan@gmail.com
Contact: Fuat Emre Canpolat, M.D. femrecan@gmail.com

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Middle Anatolia, Turkey, 06600
Contact: Sadık Yurttutan, M.D    0905059079727      
Contact: Fuat Emre Canpolat, M.D.       femrecan@gmail.com   
Principal Investigator: Sadık Yurttutan, M.D.         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Study Director: Ugur Dilmen, Prof. Dr. Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Responsible Party: Sadik Yurttutan, Fellowship of neonatology, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01652118     History of Changes
Other Study ID Numbers: 05059079727
First Submitted: July 22, 2012
First Posted: July 27, 2012
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital:
bronchopulmonary dysplasia
clarithromycin
preterm babies

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors