Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis (Claprum)
|ClinicalTrials.gov Identifier: NCT01652118|
Recruitment Status : Unknown
Verified July 2012 by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was: Recruiting
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia||Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia Drug: Saline||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||January 2013|
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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652118
|Contact: Sadık Yurttutan, M.Dfirstname.lastname@example.org|
|Contact: Fuat Emre Canpolat, M.D.||email@example.com|
|Zekai Tahir Burak Maternity Teaching Hospital||Recruiting|
|Ankara, Middle Anatolia, Turkey, 06600|
|Contact: Sadık Yurttutan, M.D 0905059079727|
|Contact: Fuat Emre Canpolat, M.D. firstname.lastname@example.org|
|Principal Investigator: Sadık Yurttutan, M.D.|
|Study Director:||Ugur Dilmen, Prof. Dr.||Zekai Tahir Burak Women's Health Research and Education Hospital|