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

July 26, 2012 updated by: Sadik Yurttutan, Zekai Tahir Burak Women's Health Research and Education Hospital

Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin

The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Middle Anatolia
      • Ankara, Middle Anatolia, Turkey, 06600
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital
        • Contact:
        • Contact:
          • Sadık Yurttutan, M.D
          • Phone Number: 0905059079727
        • Principal Investigator:
          • Sadık Yurttutan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 2 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all infant must be under 1250 gram birth weight

Exclusion Criteria:

  • Major congenital anomaly,
  • CardiaC abnormality,
  • without inform consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Clarithromycin
Fist group treated with clarithromycin which is include 10 days application.
Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
Other Names:
  • Claprum
PLACEBO_COMPARATOR: placebo
Second group treated with salin as same as amount of clarithromycine volume
Drug: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28. day of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Study Director: Ugur Dilmen, Prof. Dr., Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

January 1, 2013

Study Registration Dates

First Submitted

July 22, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (ESTIMATE)

July 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05059079727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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