Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
Information source: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lung Disease
Intervention: Clarithromycin (Drug); Dextrose (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Zekai Tahir Burak Women's Health Research and Education Hospital Official(s) and/or principal investigator(s): Omer Erdeve, Ass Prof, Study Director, Affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital Evrim Alyamac Dizdar, MD, Principal Investigator, Affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
Secondary outcome: To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.
Eligibility
Minimum age: N/A.
Maximum age: 2 Days.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Zekai Tahir Burak Maternity Teaching Hospital Neonatology department, Ankara 06600, Turkey
Additional Information
Starting date: May 2008
Last updated: March 29, 2011
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