Tesis

Pengaruh Pemberian Azitromisin Terhadap Kejadian Displasia Bronkopulmonal pada Bayi Extremely Preterm dan Very Preterm = Effect of Azithromycin on the Incidence of Bronchopulmonary Dysplasia in Extremely Preterm and Very Preterm Infants.

Latar belakang. Displasia bronkopulmonal (DBP) adalah penyakit multifaktorial kronis akibat inflamasi baik prenatal maupun postnatal. Hal ini akan menyebakan komplikasi jangka panjang dalam hal pernapasan, kardiovaskuler, dan neurodevelopmental. Azitromisin sebagai agen antiinflamasi diharapkan dapat mencegah kejadian DBP. Metode. Uji klinis acak terkontrol tidak tersamar dilakukan selama Juni 2021-April 2022 di unit Neonatologi RSCM Jakarta pada 114 subjek dengan usia gestasi 25 minggu-31 minggu 6 hari yang mengalami distress napas. Pasien yang memenuhi kriteria inklusi dan eksklusi dilakukan randomisasi dan dibagi menjadi dua kelompok yaitu kelompok uji/perlakuan dan kelompok kontrol, masing masing sebanyak 57 subjek. Kelompok uji akan mendapatkan azitromisin dalam usia < 24 jam selama 14 hari dengan dosis 10 mg/kgbb/intravena selama 7 hari kemudian dilanjutkan 5 mg/kgbb/intravena selama 7 hari. Pasian akan dipantau sampai dengan usia gestasi 36 minggu untuk melihat outcome primer berupa DBP, dan outcome sekunder berupa IVH, PVL, EKN, lama penggunaan O2, durasi penggunaan ventilator mekanik, lama pencapaian full enteral feeding, serta mortalitas pada kedua kelompok. Diagnosis DBP ditegakkan berdasarkan NICHD 2019. Hasil. Angka kejadian DBP secara umum adalah 34.8%. Angka kejadian DBP pada bayi extremely preterm adalah 58.3%, sedangkan pada bayi very preterm adalah 31%. Kejadian DBP lebih banyak pada kelompok kontrol (63% vs 38%) dengan RR 0.611(0.417-0.896). Durasi penggunaan ventilator mekanik lebih pendek pada kelompok yang mendapatkan azitromisin (5.22 vs 12.75,p 0.025). Lamanya pencapaian full enteral feeding lebih pendek pada kelompok uji/perlakuan (13.38 vs 17.14 hari, p 0.04). Angka kejadian EKN lebih rendah pada kelompok uji/perlakuan (19% vs 40%, nilai p 0.014). Mortalitas lebih rendah pada kelompok uji/perlakuan (25% vs 46% , nilai p 0.019) RR 1.660 (95% CI 1.043-2.642). Kesimpulan. Azitromisin dapat menurunkan angka kejadian DBP, mempercepat pencapaian full enteral feeding, menurunkan mortalitas pada bayi prematur.
Kata Kunci. Azitromisin, displasia bronkopulmonal, extremely preterm, very preterm.


Background. Bronchopulmonary dysplasia (BPD) is a chronic multifactorial disease caused by inflammation both prenatal and postnatal. This will lead a long-term complications of respiratory, cardiovascular, and neurodevelopmental. Azithromycin as an antiinflammatory agent is expected to prevent BPD. Methods. A randomized controlled clinical trial, unblinded was conducted during June 2021-April 2022 at the Neonatology unit of RSCM Jakarta on 114 subjects with a gestational age of 25 weeks-31 weeks 6 days who experienced respiratory distress. Patients who met the inclusion and exclusion criteria were randomized and divided into two groups, the intervention group and the control group, each group with 57 subjects. The intervention group will receive azithromycin at the age of < 24 hours for 14 days at a dose of 10 mg/kg/intravenous for 7 days then followed by 5 mg/kg/intravenous for 7 days. Patients will be monitored up to 36 weeks' gestation to see the primary outcome in the form of BPD, and secondary outcomes in the form of IVH, PVL, EKN, duration of O2 used, duration of mechanical ventilator used, duration of achieving full enteral feeding, and mortality in both groups. BPD diagnosed based on NICHD 2019. Results. The incidence of BPD in general is 34.8%. The incidence of BPD in extremely preterm infants is 58.3%, while in very preterm infants it is 31%. The incidence of BPD was more in the control group (63% vs 38%) with an RR 0.611(0.417-0.896). The duration of ventilator mechanic used was shorter in the intervention group (5.22 vs 12.75, p 0.025). The duration of achieving full enteral feeding was shorter in the intervention group (13.38 vs 17.14 days, p 0.04). The incidence of NEC was lower in the intervention group (19% vs 40%, p-value 0.014). Mortality was lower in the intervention group (25% vs 46%, p 0.019) RR 1.660 (95% CI 1.043-2.642). Conclusion. Azithromycin can reduce the incidence of BPD, accelerate the achievement of full enteral feeding, reduce mortality in premature infants.
Keywords. Azithromycin, bronchopulmonary dysplasia, extremely preterm, very preterm.