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

Phase 4

Completed

• Conditions: Bronchopulmonary Dysplasia; Intraventricular Hemorrhage; Necrotizing Enterocolitis
• Interventions: Drug: Azithromycin Powder

• Registration Number: NCT05311228
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Study First Submitted: 2022-01-22
• Primary Completion: 2022-03-01
• Study First Submitted QC: 2022-03-27
• Study Completion: 2022-04-01
• Study First Posted: 2022-04-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• multiple congenital anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bronchopulmonaty Dysplasia	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	Use of oxygen suplemantation at least 28 days until 36 weeks PMA

Secondary Outcome Measures

Name	Time	Method
Intraventricular hemorrhage	1 days-7 days, and 6 weeks	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
Necrotizing Enterocolitis	1 days-36 weeks PMA	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

Trial Locations

Locations (1)

University of Indonesia; 🇮🇩 Jakarta, DKI Jakarta, Indonesia