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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 3

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Saline; Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia

Study type: Interventional

Funder types: Other

Identifiers

NCT01652118

05059079727

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 1 hour to 2 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all infant must be under 1250 gram birth weight

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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250 participants in 2 patient groups, including a placebo group

Clarithromycin

Active Comparator group

Description:

Fist group treated with clarithromycin which is include 10 days application.

Treatment:

Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia

placebo

Placebo Comparator group

Description:

Second group treated with salin as same as amount of clarithromycine volume

Treatment:

Drug: Saline