Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
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|ClinicalTrials.gov Identifier: NCT01326611|
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : March 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lung Disease||Drug: Clarithromycin Drug: Dextrose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||273 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: Clarithromycine Group: Active Comparator
Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
Placebo Comparator: Placebo Group: Placebo Comparator
Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.
- To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges [ Time Frame: 12 days after treatment by clarithromycin ]Efficacy of clarithromycin in eradication of Ureaplasma and incidence of CLD were the major outcomes of the study. Nasopharyngeal swabs for Ureaplasma were taken in postnatal first 3 days and on the 12th day only in culture positive infants, transported to the laboratory and cultured for Uu immediately.
- To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization. [ Time Frame: From first day of inclusion of study to at postpartum 36th week of day ]Efficacy of clarithromycin in eradication of Ureaplasma urealyticum and incidence of chronic lung disease were the major outcomes of the study. Chronic lung disease of newborn was defined as a persistent oxygen requirement at 36 weeks post menstrual age or death.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326611
|Zekai Tahir Burak Maternity Teaching Hospital Neonatology department|
|Ankara, Turkey, 06600|
|Study Director:||Omer Erdeve, Ass Prof||Zekai Tahir Burak Women's Health Research and Education Hospital|
|Principal Investigator:||Evrim Alyamac Dizdar, MD||Zekai Tahir Burak Women's Health Research and Education Hospital|