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

Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01652118
Acronym
Claprum
Enrollment
250
Registered
2012-07-27
Start date
2011-10-31
Completion date
2013-01-31
Last updated
2012-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

bronchopulmonary dysplasia, clarithromycin, preterm babies

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.

Interventions

DRUGclarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
DRUGSaline

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Days
Healthy volunteers
No

Inclusion criteria

* all infant must be under 1250 gram birth weight

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Bronchopulmonary dysplasia28. day of birthOn the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia

Secondary

MeasureTime frameDescription
Overall survivalParticipants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeksDuring 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSadık Yurttutan, M.D
sdkyurttutan@gmail.com0905059079727
Backup ContactFuat Emre Canpolat, M.D.
femrecan@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026