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

Primary Purpose

Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
Saline
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring bronchopulmonary dysplasia, clarithromycin, preterm babies

Eligibility Criteria

1 Hour - 2 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all infant must be under 1250 gram birth weight

Exclusion Criteria:

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

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Clarithromycin

placebo

Arm Description

Fist group treated with clarithromycin which is include 10 days application.

Second group treated with salin as same as amount of clarithromycine volume

Outcomes

Primary Outcome Measures

Bronchopulmonary dysplasia
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia

Secondary Outcome Measures

Overall survival
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.

Full Information

First Posted
July 22, 2012
Last Updated
July 26, 2012
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01652118
Brief Title
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis
Acronym
Claprum
Official Title
Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
bronchopulmonary dysplasia, clarithromycin, preterm babies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clarithromycin
Arm Type
Active Comparator
Arm Description
Fist group treated with clarithromycin which is include 10 days application.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Second group treated with salin as same as amount of clarithromycine volume
Intervention Type
Drug
Intervention Name(s)
clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
Other Intervention Name(s)
Claprum
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Bronchopulmonary dysplasia
Description
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia
Time Frame
28. day of birth
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks

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: all infant must be under 1250 gram birth weight Exclusion Criteria: Major congenital anomaly, CardiaC abnormality, without inform consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sadık Yurttutan, M.D
Phone
0905059079727
Email
sdkyurttutan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fuat Emre Canpolat, M.D.
Email
femrecan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ugur Dilmen, Prof. Dr.
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
State/Province
Middle Anatolia
ZIP/Postal Code
06600
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadık Yurttutan, M.D
Phone
0905059079727
First Name & Middle Initial & Last Name & Degree
Fuat Emre Canpolat, M.D.
Email
femrecan@gmail.com
First Name & Middle Initial & Last Name & Degree
Sadık Yurttutan, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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