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

Study Overview
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Brief Summary
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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

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

Conditions
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Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis

Intervention / Treatment
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* Drug: Azithromycin Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premature infant 25-31 weeks 6 days with respiratory distress, Exclusion Criteria: multiple congenital anomaly

Ages Eligible for Study
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Minimum Age: 25 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups, one group intervention and one group control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours | Drug: Azithromycin Powder<br>* Azithromicyn intravena for 14 days<br>|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonaty Dysplasia | Use of oxygen suplemantation at least 28 days until 36 weeks PMA | BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraventricular hemorrhage | Sign of IVH from head ultrasonography from USG we can found the sign of IVH grade 1 if we perform head USG and we found bleeding in germinal matriks grade 2 if we perform head USG and we found bleeding intaventricular without ventricle dilatation grade 3 if we perform head USG we found bleeding intraventrucular with dilatation of ventricle grade 4 if we perform head USG and we found bleeding in parenchime Head USG perform at 1-7 days and then in 6 weeks | 1 days-7 days, and 6 weeks | 
| Necrotizing Enterocolitis | Sign and symptoms of NEC from clinical, laboratory, and radiology If we found : From clinical sign : temperature < 36.5 degree C or > 37.5 degree C, Respiratory rate > 60/min with retraction, abdominal distention Laboratory examination : trombocyte < 100.000/mm3, natrium <135 meq/L, pH < 7.1, BE > -12, CRP > 5 IU Radiology examination : sign of pneumatosis intestinalis NEC : clinically + laboratory + radiology | 1 days-36 weeks PMA |