Tesis

Pemberian Lactobacillus reuteri DSM 17938 pada bayi prematur di Rumah Sakit Dr. Cipto Mangunkusumo : kajian terhadap kejadian enterokolitis nekrotikans = Oral Administration of Lactobacillus reuteri DSM 17938 in Preterm Infants at Dr. Cipto Mangunkusumo Hospital: A Study towards the Prevalence of Necrotizing Enterocolitis.

Latar belakang: Enterokolitis nekrotikans (EKN) merupakan penyakit inflamasi pada saluran cerna yang sering terjadi pada bayi prematur. Lactobacillus reuteri merupakan mikroorganisme hidup yang dilaporkan dapat mencegah kejadian EKN, intoleransi minum dan menurunkan angka mortalitas. Tujuan: Mengidentifikasi angka kejadian EKN pada bayi prematur yang mendapat Lactobacillus reuteri DSM 17938 dan sekunder angka kejadian sepsis, intoleransi minum, waktu mencapai full feeding, lama hari perawatan, efek samping dan kematian. Metode: Uji klinis prospektif acak tersamar ganda membandingkan pemberian Lactobacillus reuteri DSM 17938 dengan plasebo pada neonatus dengan usia gestasi 28-34 minggu dan berat lahir 1000-1800 gram. Masing-masing kelompok terdiri dari 47 subjek yang dievaluasi antara Maret – Oktober 2017 di Rumah Sakit Dr. Cipto Mangunkusumo. Hasil: Nilai tengah usia gestasi adalah 33 minggu (28-34) pada kedua kelompok. Nilai tengah berat lahir kelompok probiotik 1520 gram (1035-1800) dan plasebo 1605 gram (1060-1800) (p=0,77). Kejadian EKN (stadium 2 dan 3) didapatkan 3 subjek (6,4%) pada kelompok plasebo dan tidak ada ada kelompok probiotik (RR 1,07 IK 95% 0,99-1,15, p=0,24). Intoleransi minum (berupa muntah, kembung, atau keduanya) lebih rendah pada kelompok probiotik dibandingkan plasebo (8,5% vs. 25,5%, RR 0,33 IK 95% 0,12-0,96, p=0,03). Proven sepsis pada kelompok probiotik dan plasebo tidak berbeda bermakna (2,1% vs. 6,4%, p=0,62). Waktu mencapai full feeding dan lama perawatan tidak didapatkan perbedaan bermakna antara kedua kelompok. Efek samping yang diobservasi berupa diare tidak berbeda bermakna antara kelompok probiotik dan plasebo (2,1% vs. 4,3%, p=1,00). Kematian tidak berbeda bermakna antara kelompok probiotik dibandingkan plasebo (2,1% vs. 8,5%, p=0,36). Simpulan: Kejadian EKN terjadi pada kelompok plasebo sebesar 6,4% dan tidak ada pada kelompok probiotik. Intoleransi minum secara bermakna lebih rendah pada kelompok probiotik dibandingkan plasebo. Luaran sekunder proven sepsis, waktu mencapai full feeding, lama perawatan, efek samping (diare) dan kematian tidak didapatkan perbedaan bermakna antara kedua kelompok.
Kata kunci: Lactobacillus reuteri, prematur, enterokolitis nekrotikans


Background: Necrotizing enterocolitis (NEC) is an inflammatory disorder of the gastrointestinal tract that often occurs in preterm infants. Lactobacillus reuteri is a living microorganism that has been reported to prevent the occurrence of NEC, feeding intolerance, and decrease mortality rate. Objectives: The objective of this study is to identify the NEC prevalence in preterm infants receiving Lactobacillus reuteri DSM 17938 with secondary outcomes including sepsis occurrence, feeding intolerance, time to reach full feeding, length of stay, adverse effects, and mortality. Methods: This study is a double-blind randomized controlled trial of Lactobacillus reuteri DSM 17938 in comparison with placebo in neonates with the gestational age between 28 to 34 weeks and birth weight between 1000-1800 grams. Each trial group consisted of 47 subjects that were monitored between March until October 2017 at Dr. Cipto Mangunkusumo Hospital. Results: The median gestational age in this study was 33 weeks (range 28-34) in both trial groups. The median birth weight of the probiotic group was 1520 grams (range 1035-1800) and 1605 grams (range 1060-1800) in the placebo group (p=0.77). The prevalence of NEC (stages 2 and 3) were found in three subjects (6,4%) of the placebo group whereas none occurred in the probiotic group (RR 1.07, 95% CI 0.99-1.15, p=0.24). Feeding intolerance (in the form of vomiting, distension, or both) were found to be lower in the probiotic group (8.5%) compared to the placebo group (25.5%) with the RR 0.33 (95% CI 0.12-0.96, p=0.03). The rate of proven sepsis were not found to be significantly difference in both trial groups (2.1% in the probiotic group and 6.4% in the placebo group, p=0.62). No significant differences were found between both groups for the time to reach full feeding and length of stay. The observed adverse effects of diarrhea was not found to be significantly difference in both groups (2.1% in the probiotic group and 4.3% in the placebo group, p=1.00). Mortality rates were also not statistically significant between both groups (2.1% in the probiotic group and 8.5% in the placebo group, p=0.36). Conclusion: 6,4% of the placebo group experienced NEC whereas none occurred in the probiotic group. Feeding intolerance was found to be significantly lower in the group receiving probiotics compared to the placebo group. Secondary outcomes including proven sepsis, time to reach full feeding, length of stay, adverse effect (diarrhea), and mortality were also not found to be significantly different between both trial groups.
Keywords: Lactobacillus reuteri, preterm, necrotizing enterocolitis