Effects of the early administration of sivelestat sodium on bronchopulmonary dysplasia in infants: A retrospective cohort study.

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.

• Authors: Ryo Ogawa, Rintaro Mori, Koichi Iida, Yumiko Uchida, Makoto Oshiro, Misao Kageyama, Yuichi Kato, Taihei Tanaka, Yusei Nakata, Yutaka Nishimura, Isamu Hokuto, Motoki Bonno, Naoko Matsumoto, Masato Ito, Noriko Takahashi, Fumihiko Namba
• Journal: Early human development (Early Hum Dev) Vol. 115 Pg. 71-76 (12 2017) ISSN: 1872-6232 [Electronic] Ireland
• PMID: 28950234 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 Elsevier B.V. All rights reserved.

Chemical References

• Serine Proteinase Inhibitors
• Sulfonamides
• sivelestat
• Glycine

Topics

• Bronchopulmonary Dysplasia (drug therapy)
• Drug Administration Schedule
• Female
• Glycine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Infant, Newborn
• Infant, Premature
• Infant, Small for Gestational Age
• Male
• Serine Proteinase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Sulfonamides (administration & dosage, adverse effects, therapeutic use)