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

NCT05311228 | Completed Phase 4 DMC

• 1 other identifier: 21050544
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchopulmonary Dysplasia; Intraventricular Hemorrhage; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intraventricular hemorrhage

  1 days-7 days, and 6 weeks

• Necrotizing Enterocolitis

  1 days-36 weeks PMA

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention

Interventions

Azithromycin Powder DRUG

Azithromicyn intravena for 14 days

Intervention group

Eligibility Criteria

• Age: 25 Weeks - 32 Weeks
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• multiple congenital anomaly

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

University of Indonesia

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Besse Sarmila, Sp.A, trainee subspecialist neonatology division, principle investigator, clinicalpediatrician

Model Details: Two groups, one group intervention and one group control

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: April 5, 2022
• Study Start: June 8, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

ID (1)