Synthetic surfactant for respiratory distress syndrome in preterm infants

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Abstract
This section is under preparation and will be included in the next issue. To assess the effect of intratracheal administration of synthetic surfactant in premature newborns with established respiratory distress syndrome (RDS). Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactants; limits: age groups, newborn infant; publication types, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. Randomized controlled trials which compared the effect of synthetic surfactant treatment to routine management in the treatment of preterm infants with respiratory distress syndrome. Data regarding clinical outcome including the incidence of pneumothorax, pulmonary interstitial emphysema, pulmonary hemorrhage, patent ductus arteriosus, necrotizing enterocolitis, apnea of prematurity, intraventricular hemorrhage (any grade, and severe intraventricular hemorrhage), bronchopulmonary dysplasia, neonatal mortality, bronchopulmonary dysplasia or death, retinopathy of prematurity (any retinopathy, and retinopathy greater than Stage 3), mortality at hospital discharge, mortality to one year of age, and cerebral palsy (any, and moderate/severe cerebral palsy) was excerpted from the report of the clinical trials by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group. Six randomized controlled trials of synthetic surfactant treatment of established respiratory distress syndrome were identified. Five of the studies used Exosurf Neonatal (a synthetic surfactant composed of dipalmitoylphosphatidylcholine, hexadecanol and tyloxapol); one small study utilized a mixture of dipalmitoylphosphatidylcholine (DPPC) and phosphatidylglycerol (PG). Treatment with intratracheal Exosurf Neonatal in premature infants with established respiratory distress syndrome improves pulmonary gas exchange and decreases the requirement for ventilatory support. In individual trials, the use of Exosurf Neonatal resulted in a statistically significant reduction in pneumothorax, patent ductus arteriosus, bronchopulmonary dysplasia (BPD), BPD or death at 28 days, and mortality. Similar results are seen when these large trials of Exosurf Neonatal are analyzed in conjunction with the smaller trial of dry powdered DPPC and phosphatidylglycerol (PG). The meta‐analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.64, 95% CI 0.55, 0.76, typical risk difference ‐0.09, 95% CI ‐0.12,‐0.06), a decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.62, 95% CI 0.54, 0.71, typical risk difference ‐0.12, 95% CI ‐0.16, ‐0.09), a decrease in the risk of patent ductus arteriosus (typical relative risk 0.90, 95% CI 0.84, 0.97; typical risk difference ‐0.06 95% CI ‐0.10, ‐0.02), a decrease in the risk of intraventricular hemorrhage (typical relative risk 0.88, 95% CI 0.77, 0.99; typical risk difference ‐0.04, 95% CI ‐0.08, ‐0.00), a decrease in the risk of bronchopulmonary dysplasia (typical relative risk 0.75, 95% CI 0.61, 0.92; typical risk difference ‐0.04, 95% CI ‐0.06, ‐0.01), a decrease in the risk of neonatal mortality (typical relative risk 0.73, 95% CI 0.61, 0.88; typical risk difference ‐0.05, 95% CI ‐0.07, ‐0.02), a decrease in the risk of bronchopulmonary dysplasia or death at 28 days (typical relative risk 0.73, 95% CI 0.65, 0.83; typical risk difference ‐0.06, 95% CI ‐0.11, ‐0.05), a decrease in the risk of mortality prior to hospital discharge (typical relative risk 0.79, 95% CI 0.68, 0.92; typical risk difference ‐0.05, 95% CI ‐0.07, ‐0.02) and a decrease in the risk of mortality during the first year of life (typical relative risk 0.80, 95% CI 0.69, 0.94; typical risk difference ‐0.04, 95% CI ‐0.07, ‐0.01). Treatment with synthetic surfactant increases the risk of apnea of prematurity (typical relative risk 1.20, 95% CI 1.09, 1.31; typical risk difference 0.08, 95% CI 0.04, 0.12). Intratracheal administration of synthetic surfactant to infants with established respiratory distress syndrome has been demonstrated to improve clinical outcome. Infants who are treated with synthetic surfactant have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, a decreased risk of intraventricular hemorrhage, a decreased risk of bronchopulmonary dysplasia, a decreased risk of neonatal mortality, a decreased risk of mortality prior to hospital discharge and at 1 year of age. Infants who receive synthetic surfactant treatment for established RDS have an increased risk of apnea of prematurity. 以合成性表面張力素治療早產兒呼吸窘迫症候群(respiratory distress syndrome) 本節正在準備之中，將列入下一個議題。 為了評估經氣管內給予早產兒合成性表面張力素以治療新生兒呼吸窘迫症候群的功效。 檢索了牛津周產期試驗數據庫，Medline(醫學標題表：肺表面張力素; 限制：年齡組，新生兒; 出版物類型，臨床試驗)，前幾次檢閱包括交叉引用、摘要、會議和研討會論文集，專家信息和英語的手工檢索。 隨機對照試驗以比較使用合成性表面張力素在常規治療新生兒呼吸窘迫症候群的效果 和臨床預後有關的數據，包括氣胸、肺間質氣腫、肺出血、開放性動脈導管、壞死性小腸結腸炎、早產兒呼吸暫停、腦室內出血(任何級別和嚴重腦室內出血)、支氣管肺發育不良或死亡、早產兒視網膜病變(任何視網膜病變，和視網膜病變等級大於3)等的發生率、出院時之死亡率、至一歲時之死亡率及腦性麻痺 任何嚴重度和中/重度腦性麻痺)是由審閱者摘自臨床試驗的報告內容。數據分析是根據Cochrane新生兒評估組的標準來作。...

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