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

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ClinicalTrials.gov Identifier: NCT01326611
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : March 31, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

Tracking Information
First Submitted Date  ICMJE March 29, 2011
First Posted Date  ICMJE March 31, 2011
Last Update Posted Date March 31, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Chronic Lung Disease
Intervention  ICMJE
  • Drug: Clarithromycin
  • Drug: Dextrose
Study Arms  ICMJE
  • Active Comparator: Clarithromycine Group: Active Comparator
    Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
    Intervention: 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.
    Intervention: Drug: Dextrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2011)
273
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01326611
Other Study ID Numbers  ICMJE rö05053781128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Zekai Tahir Burak Women's Health Research and Education Hospital
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP