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

NCT ID: NCT05311228

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2022-04-01

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

Detailed Description

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Conditions

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Bronchopulmonary Dysplasia Intraventricular Hemorrhage Necrotizing Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups, one group intervention and one group control
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Azithromycin Powder

Intervention Type DRUG

Azithromicyn intravena for 14 days

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Azithromycin Powder

Azithromicyn intravena for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* multiple congenital anomaly
Minimum Eligible Age

25 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Besse Sarmila

dr. Besse Sarmila, Sp.A, trainee subspecialist neonatology division, principle investigator, clinicalpediatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Indonesia

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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21050544

Identifier Type: -

Identifier Source: org_study_id

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