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Trial record 37 of 428 for:    CLARITHROMYCIN

Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis (Claprum)

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.
 
ClinicalTrials.gov Identifier: NCT01652118
Recruitment Status : Unknown
Verified July 2012 by Sadik Yurttutan, Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Sadik Yurttutan, Zekai Tahir Burak Women's Health Research and Education Hospital

Tracking Information
First Submitted Date  ICMJE July 22, 2012
First Posted Date  ICMJE July 27, 2012
Last Update Posted Date July 27, 2012
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
Bronchopulmonary dysplasia [ Time Frame: 28. day of birth ]
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
Overall survival [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks ]
During to hospitalisation the investigator will determine and record some co-morbidities of BPD such as intracranial hemorrhage, necrotizing enterocolitis, patent ductus arteriosus rates.From date of randomization until the end of the hospitalisation up to the 3 months of life.
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 Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis
Official Title  ICMJE Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
Brief Summary The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.
Detailed Description

The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.

The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE
  • Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
    Other Name: Claprum
  • Drug: Saline
Study Arms  ICMJE
  • Active Comparator: Clarithromycin
    Fist group treated with clarithromycin which is include 10 days application.
    Intervention: Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
  • Placebo Comparator: placebo
    Second group treated with salin as same as amount of clarithromycine volume
    Intervention: Drug: Saline
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 26, 2012)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all infant must be under 1250 gram birth weight

Exclusion Criteria:

  • Major congenital anomaly,
  • CardiaC abnormality,
  • without inform consent
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 NCT01652118
Other Study ID Numbers  ICMJE 05059079727
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sadik Yurttutan, Zekai Tahir Burak Women's Health Research and Education Hospital
Study Sponsor  ICMJE Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ugur Dilmen, Prof. Dr. Zekai Tahir Burak Women's Health Research and Education Hospital
PRS Account Zekai Tahir Burak Women's Health Research and Education Hospital
Verification Date July 2012

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