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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clarithromycine Group: Active Comparator | Active Comparator | Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days) |
|
| Placebo Group: Placebo Comparator | Placebo Comparator | Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin | Drug |
| ||
| Dextrose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges | 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. | 12 days after treatment by clarithromycin |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omer Erdeve, Ass Prof | Zekai Tahir Burak Women's Health Research and Education Hospital | Study Director |
| Evrim Alyamac Dizdar, MD | Zekai Tahir Burak Women's Health Research and Education Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak Maternity Teaching Hospital Neonatology department | Ankara | 06600 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| From first day of inclusion of study to at postpartum 36th week of day |
| Organic Chemicals |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |