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

Chronic Lung Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326611
• Other study ID #: rö05053781128
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: March 29, 2011
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2008
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases

Intervention

Drug:
• Clarithromycin

• Dextrose

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital Neonatology department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	From first day of inclusion of study to at postpartum 36th week of day	Yes