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

Phase 3

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia; Drug: Saline

• Registration Number: NCT01652118
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

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 Timeline

• Study Start: 2011-10
• Status Verified: 2012-07
• Study First Submitted: 2012-07-22
• Study First Submitted QC: 2012-07-26
• Last Update Submitted: 2012-07-26
• Study First Posted: 2012-07-27
• Last Update Posted: 2012-07-27
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• all infant must be under 1250 gram birth weight

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clarithromycin	clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia	Fist group treated with clarithromycin which is include 10 days application.
placebo	Saline	Second group treated with salin as same as amount of clarithromycine volume

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	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.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital; 🇹🇷 Ankara, Middle Anatolia, Turkey