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

NCT ID: NCT01652118

Last Updated: 2012-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Bronchopulmonary Dysplasia

Keywords

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bronchopulmonary dysplasia clarithromycin preterm babies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Clarithromycin

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

Group Type ACTIVE_COMPARATOR

clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia

Intervention Type DRUG

placebo

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia

Intervention Type DRUG

Saline

Intervention Type DRUG

Other Intervention Names

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Claprum

Eligibility Criteria

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Inclusion Criteria

* all infant must be under 1250 gram birth weight

Exclusion Criteria

* Major congenital anomaly,
* CardiaC abnormality,
* without inform consent
Minimum Eligible Age

1 Hour

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sadik Yurttutan

Fellowship of neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ugur Dilmen, Prof. Dr.

Role: STUDY_DIRECTOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

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Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Middle Anatolia, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sadık Yurttutan, M.D

Role: CONTACT

Phone: 0905059079727

Email: [email protected]

Fuat Emre Canpolat, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sadık Yurttutan, M.D

Role: primary

Fuat Emre Canpolat, M.D.

Role: backup

Other Identifiers

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05059079727

Identifier Type: -

Identifier Source: org_study_id