Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Completed; Phase 4

Conditions: Chronic Lung Disease

Treatments: Drug: Dextrose; Drug: Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01326611

rö05053781128

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.

Enrollment: 273 patients

Sex: All

Ages: 1 hour to 2 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The babies under 1250 gram
• The babies must be appropriate for gestational age

Exclusion criteria

• Multiple congenital anomalies or known syndromes
• Intrauterine growth retardation with birthweight less than 10 percentile for gestational age

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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273 participants in 2 patient groups, including a placebo group

Clarithromycine Group: Active Comparator

Active Comparator group

Description:

Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)

Treatment:

Drug: Clarithromycin

Placebo Group: Placebo Comparator

Placebo Comparator group

Description:

Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.

Treatment:

Drug: Dextrose