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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

Page last updated: August 23, 2015

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