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Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

NCT ID: NCT01326611

Last Updated: 2011-03-31

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Lung Disease

Keywords

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Chronic lung disease Clarithromycin Ureaplasma urealyticum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Clarithromycine Group: Active Comparator

Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

Placebo Group: Placebo Comparator

Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.

Group Type PLACEBO_COMPARATOR

Dextrose

Intervention Type DRUG

Interventions

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Clarithromycin

Intervention Type DRUG

Dextrose

Intervention Type DRUG

Eligibility Criteria

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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
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

Principal Investigators

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Omer Erdeve, Ass Prof

Role: STUDY_DIRECTOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Evrim Alyamac Dizdar, MD

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

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Zekai Tahir Burak Maternity Teaching Hospital Neonatology department

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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rö05053781128

Identifier Type: -

Identifier Source: org_study_id