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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311228
• Other study ID #: 21050544
• Status: Completed
• Phase: Phase 4
• Start date: June 8, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• multiple congenital anomaly

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Enterocolitis
• Enterocolitis, Necrotizing
• Hemorrhage
• Intraventricular Hemorrhage
• Necrotizing Enterocolitis

Intervention

Drug:
• Azithromycin Powder
Azithromicyn intravena for 14 days

Locations

Country	Name	City	State
Indonesia	University of Indonesia	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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