Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
- To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges [ Time Frame: 12 days after treatment by clarithromycin ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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.
|Zekai Tahir Burak Maternity Teaching Hospital Neonatology department|
|Ankara, Turkey, 06600|
|Study Director:||Omer Erdeve, Ass Prof||Zekai Tahir Burak Maternity Teaching Hospital|
|Principal Investigator:||Evrim Alyamac Dizdar, MD||Zekai Tahir Burak Maternity Teaching Hospital|