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Completed

NCT Number: NCT05311228

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

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

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Intestinal Diseases Intraventricular Hemorrhage Lung Diseases Lung Injury Necrotizing Enterocolitis Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

25 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Indonesia

Jakarta, DKI Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • multiple congenital anomaly

Treatment and study plan

Azithromycin Powder

Drug

Azithromicyn intravena for 14 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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