Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis
Claprum
Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
1 other identifier
interventional
250
1 country
1
Brief Summary
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 22, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJuly 27, 2012
July 1, 2012
1.2 years
July 22, 2012
July 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bronchopulmonary dysplasia
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia
28. day of birth
Secondary Outcomes (1)
Overall survival
Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks
Study Arms (2)
Clarithromycin
ACTIVE COMPARATORFist group treated with clarithromycin which is include 10 days application.
placebo
PLACEBO COMPARATORSecond group treated with salin as same as amount of clarithromycine volume
Interventions
Eligibility Criteria
You may qualify if:
- all infant must be under 1250 gram birth weight
You may not qualify if:
- Major congenital anomaly,
- CardiaC abnormality,
- without inform consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Middle Anatolia, 06600, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ugur Dilmen, Prof. Dr.
Zekai Tahir Burak Women's Health Research and Education Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellowship of neonatology
Study Record Dates
First Submitted
July 22, 2012
First Posted
July 27, 2012
Study Start
October 1, 2011
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
July 27, 2012
Record last verified: 2012-07