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

Bronchopulmonary Dysplasia Clinical Trial

— Claprum  

Official title:

Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01652118
• Other study ID #: 05059079727
• Status: Recruiting
• Phase: Phase 3
• First received: July 22, 2012
• Last updated: July 26, 2012
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2012
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Sadik Yurttutan, M.D
• Phone: 0905059079727
• Email: sdkyurttutan[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

• all infant must be under 1250 gram birth weight

Exclusion Criteria:

• Major congenital anomaly,

• CardiaC abnormality,

• without inform consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Drug:
• clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia

• Saline

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara	Middle Anatolia

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchopulmonary dysplasia	On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia	28. day of birth	Yes
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks	Yes