Back to resultsEfficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
Primary Purpose
Chronic Lung Disease
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Clarithromycin
Dextrose
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Lung Disease focused on measuring Chronic lung disease, Clarithromycin, Ureaplasma urealyticum
Eligibility 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
Sites / Locations
- Zekai Tahir Burak Maternity Teaching Hospital Neonatology department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Clarithromycine Group: Active Comparator
Placebo Group: Placebo Comparator
Arm Description
Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.
Outcomes
Primary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01326611
First Posted
March 29, 2011
Last Updated
March 29, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01326611
Brief Title
Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lung Disease
Keywords
Chronic lung disease, Clarithromycin, Ureaplasma urealyticum
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clarithromycine Group: Active Comparator
Arm Type
Active Comparator
Arm Description
Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
Arm Title
Placebo Group: Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Type
Drug
Intervention Name(s)
Dextrose
Primary Outcome Measure Information:
Title
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
Description
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.
Time Frame
12 days after treatment by clarithromycin
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.
Description
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.
Time Frame
From first day of inclusion of study to at postpartum 36th week of day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Erdeve, Ass Prof
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Evrim Alyamac Dizdar, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital Neonatology department
City
Ankara
ZIP/Postal Code
06600
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
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