A Phase 4 interventional study of Azithromycin Powder in Bronchopulmonary Dysplasia, Intraventricular Hemorrhage and Necrotizing Enterocolitis, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 25 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Indonesia University · Phase 4, Interventional, and Prevention
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
216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 123 interventional studies indexed under Enterocolitis.
Browse Enterocolitis studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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
No intervention
Azithromicyn intravena for 14 days
Bronchopulmonaty Dysplasia
Use of oxygen suplemantation at least 28 days until 36 weeks PMA
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
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
Time frame: 1 days-7 days, and 6 weeks
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
Time frame: 1 days-36 weeks PMA
Plan to share: Undecided — Maybe i will share IPD with other researcher
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Indonesia University