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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326611
First Posted: March 31, 2011
Last Update Posted: March 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
  Purpose
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.

Condition Intervention Phase
Chronic Lung Disease Drug: Clarithromycin Drug: Dextrose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges [ Time Frame: 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:
  • To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization. [ Time Frame: 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.


Enrollment: 273
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clarithromycine Group: Active Comparator
Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
Drug: Clarithromycin
Placebo Comparator: Placebo Group: Placebo Comparator
Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.
Drug: Dextrose

  Eligibility

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326611


Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Neonatology department
Ankara, Turkey, 06600
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Study Director: Omer Erdeve, Ass Prof Zekai Tahir Burak Women's Health Research and Education Hospital
Principal Investigator: Evrim Alyamac Dizdar, MD Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01326611     History of Changes
Other Study ID Numbers: rö05053781128
First Submitted: March 29, 2011
First Posted: March 31, 2011
Last Update Posted: March 31, 2011
Last Verified: May 2008

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
Chronic lung disease
Clarithromycin
Ureaplasma urealyticum

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors