The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Intraventricular Hemorrhage; Necrotizing Enterocolitis; Bronchopulmonary Dysplasia

Treatments: Drug: Azithromycin Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT05311228

21050544

Details and patient eligibility

About

This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA

Enrollment: 120 patients

Sex: All

Ages: 25 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• premature infant 25-31 weeks 6 days with respiratory distress,

Exclusion criteria

• multiple congenital anomaly

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours

Treatment:

Drug: Azithromycin Powder

Control group

No Intervention group

Description:

No intervention