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

March 7, 2024 updated by: Besse Sarmila, Indonesia University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • University of Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • multiple congenital anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention
Experimental: Intervention group
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
Azithromicyn intravena for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchopulmonaty Dysplasia
Time Frame: 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
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
Time Frame: 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
1 days-7 days, and 6 weeks
Necrotizing Enterocolitis
Time Frame: 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
1 days-36 weeks PMA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 22, 2022

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21050544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Maybe i will share IPD with other researcher

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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