Ryo Ogawa1, Rintaro Mori2, Koichi Iida3, Yumiko Uchida4, Makoto Oshiro5, Misao Kageyama6, Yuichi Kato7, Taihei Tanaka8, Yusei Nakata9, Yutaka Nishimura10, Isamu Hokuto11, Motoki Bonno12, Naoko Matsumoto13, Masato Ito14, Noriko Takahashi15, Fumihiko Namba16. 1. Saitama Medical Center, Saitama Medical University,1981 Kamoda Kawagoe, Saitama, Japan. Electronic address: drryo0411@gmail.com. 2. National Center for Child Health and Development, 2-10-1, Okura, Setagaya, Tokyo, Japan. Electronic address: rintaromori@gmail.com. 3. Oita Prefectural Hospital, 476, Bunyo, Oita, Japan. Electronic address: nicu@oitakenbyo.jp. 4. Nara Medical University Hospital, Center of Perinatal Medicine, 840, shijyo, Kashihara, Nara, Japan. Electronic address: rmbsh274@yahoo.co.jp. 5. Japanese Red Cross Nagoya Daiichi Hospital, 3-35, Douge, Nakamura, Nagoya, Japan. Electronic address: makoto@nagoya-1st.jrc.or.jp. 6. Okayama Medical Center, 1711-1, Tamasu, Kita, Okayama, Japan. Electronic address: misao330@okayama3.hosp.go.jp. 7. Anjo Kosei Hospital, 28, Higashikurokute, Anjo, Aichi, Japan. Electronic address: yuta416@kosei.anjo.aichi.jp. 8. Japanese Red Cross Nagoya Daini Hospital, 2-9, Myoken, ShowaNagoya, Aichi, Japan. Electronic address: taihei07@gmail.com. 9. Kochi Health Sciences Center, 2125, Ike, Kochi, Japan. Electronic address: yuusei2185@yahoo.co.jp. 10. Hiroshima City Hiroshima Citizens Hospital, 7-33, Motomachi, Naka, Hiroshima, Hiroshima, Japan. Electronic address: warabi@city-hosp.naka.hiroshima.jp. 11. St. Marianna University School of Medical Hospital, 2-16-1, Sugao, Miyamae, Kanagawa, Japan. Electronic address: isamuhokuto@gmail.com. 12. Mie Chuo Medical Center, 2158-5, Hisaimyojin, Tsu, Mie, Japan. Electronic address: bonnomo@hotmail.com. 13. Kitakyushu Municipal Medical Center, Kitakyushu Kokurakita, Fukuoka, Japan. Electronic address: mla02765@nifty.com. 14. Saitama Medical Center, Saitama Medical University,1981 Kamoda Kawagoe, Saitama, Japan. Electronic address: i1t2o3u4jp@gmail.com. 15. National Center for Child Health and Development, 2-10-1, Okura, Setagaya, Tokyo, Japan. Electronic address: furuoyanoriko@gmail.com. 16. Saitama Medical Center, Saitama Medical University,1981 Kamoda Kawagoe, Saitama, Japan. Electronic address: nambaf@saitama-med.ac.jp.
Abstract
BACKGROUND: Chorioamnionitis, or infiltration of the chorioamnion by neutrophils, is a risk factor associated with the development of bronchopulmonary dysplasia. Increased neutrophil elastase levels are observed in the tracheal aspirates of these patients. AIMS: To examine the effects of early administration of the selective neutrophil elastase inhibitor sivelestat, which is used to treat acute lung injury in adults, on bronchopulmonary dysplasia in extremely premature infants. STUDY DESIGN: Retrospective cohort study. SUBJECTS: This study included extremely low-birth-weight infants born at a gestational age<28weeks. Patients were divided into groups based on the receipt of sivelestat. OUTCOME MEASURES: The primary outcome was the rate of bronchopulmonary dysplasia-free survival at a postmenstrual age of 36weeks, and the secondary outcomes included various clinically significant factors of neonatal mortality and morbidity and adverse events. RESULTS: Of the 1031 included neonates, 124 (12.0%) were treated with sivelestat. Significant differences between the groups were noted for gestational age, delivery method, fetal number, the frequency of chorioamnionitis, immunoglobulin M levels, and WBC counts. No differences were identified concerning the bronchopulmonary dysplasia-free survival rate at a postmenstrual age of 36weeks (adjusted odds ratio for sivelestat to control, 0.83; 95% confidence interval=0.53-1.30). Secondary outcomes did not significantly differ between the groups. CONCLUSIONS: In extremely premature infants, early sivelestat use was not associated with an improved rate of survival without bronchopulmonary dysplasia at a postmenstrual age of 36weeks.
BACKGROUND:Chorioamnionitis, or infiltration of the chorioamnion by neutrophils, is a risk factor associated with the development of bronchopulmonary dysplasia. Increased neutrophil elastase levels are observed in the tracheal aspirates of these patients. AIMS: To examine the effects of early administration of the selective neutrophil elastase inhibitor sivelestat, which is used to treat acute lung injury in adults, on bronchopulmonary dysplasia in extremely premature infants. STUDY DESIGN: Retrospective cohort study. SUBJECTS: This study included extremely low-birth-weight infants born at a gestational age<28weeks. Patients were divided into groups based on the receipt of sivelestat. OUTCOME MEASURES: The primary outcome was the rate of bronchopulmonary dysplasia-free survival at a postmenstrual age of 36weeks, and the secondary outcomes included various clinically significant factors of neonatal mortality and morbidity and adverse events. RESULTS: Of the 1031 included neonates, 124 (12.0%) were treated with sivelestat. Significant differences between the groups were noted for gestational age, delivery method, fetal number, the frequency of chorioamnionitis, immunoglobulin M levels, and WBC counts. No differences were identified concerning the bronchopulmonary dysplasia-free survival rate at a postmenstrual age of 36weeks (adjusted odds ratio for sivelestat to control, 0.83; 95% confidence interval=0.53-1.30). Secondary outcomes did not significantly differ between the groups. CONCLUSIONS: In extremely premature infants, early sivelestat use was not associated with an improved rate of survival without bronchopulmonary dysplasia at a postmenstrual age of 36weeks.