Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

Phase 4

Completed

• Conditions: Chronic Lung Disease
• Interventions: Drug: Clarithromycin; Drug: Dextrose

• Registration Number: NCT01326611
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-05
• Study Start: 2008-05
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Last Update Submitted: 2011-03-29
• Study First Posted: 2011-03-31
• Last Update Posted: 2011-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• The babies under 1250 gram
• The babies must be appropriate for gestational age

Exclusion Criteria

• Multiple congenital anomalies or known syndromes
• Intrauterine growth retardation with birthweight less than 10 percentile for gestational age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clarithromycine Group: Active Comparator	Clarithromycin	Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
Placebo Group: Placebo Comparator	Dextrose	Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.	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.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital Neonatology department; 🇹🇷 Ankara, Turkey