Bovine Surfactant Replacement Therapy in Neonates of Less than 32 Weeks' Gestation: A Multicenter Controlled Trial of Prophylaxis versus Early Treatment in China--a Pilot Study.

BACKGROUND: A domestic surfactant preparation has been used in China for a number of years. However, as for other surfactant preparations, there is debate among neonatologists regarding the optimal dose, mode of administration, and the best time of intervention. OBJECTIVE: To evaluate whether prophylactic administration of surfactant is superior to early treatment in preterm infants < 32 weeks with a high risk of respiratory distress syndrome (RDS). METHODS: We prospectively compared small premature infants (< 32 weeks) receiving 70 mg/kg bovine surfactant within 30 minutes after birth (prophylactic group, N = 116) with infants who received surfactant therapy for established RDS (early treatment group, N = 91). The primary outcome assessed was the incidence of RDS. The secondary outcomes assessed were severity of RDS, mortality, and bronchopulmonary dysplasia morbidity. RESULTS: Compared with the early treatment group, the prophylactic group had a significantly better PaO2 (at 1 hour, 4 hours, and 12 hours postdose, respectively), better a/APO2 (at 1 hour, 4 hours, 12 hours, and 24 hours postdose, respectively), lower PaCO2 (at 1 hour postdose), and a significantly decreased need for mean airway pressure (MAP) and FiO2 on ventilation (p < 0.05). The prophylactic group had shorter durations for mechanical ventilation and supplemental oxygen compared with the early treatment group (p < 0.01 and p < 0.05, respectively). The incidence of RDS was comparable between the groups; however, the prophylactic group had a significantly lower incidence of severe RDS and significantly lower rate of repeated doses of surfactant than the early treatment group (p < 0.05). The incidences of bronchopulmonary dysplasia and patent ductus arteriosus were also lower in the prophylactic group than the early treatment group (p < 0.05). The two groups were comparable in mortality rate. CONCLUSION: In preterm infants under 32 weeks' gestation, prophylactic use of a domestic surfactant preparation is better than early surfactant treatment in improving pulmonary status and in decreasing the incidence of severe RDS and duration on mechanical ventilation.

Revisión sistemática y meta-análisis sobre la efectividad del surfactante bovino como tratamiento de prematuros con síndrome de dificultad respiratoria / Systematic review and meta-analysis of bovine surfactant effectiveness for the treatment of respiratory distress syndrome in premature newborns

Introducción. Con el propósito de determinar la efectividad del surfactante bovino (SB) para el tratamiento del síndrome de dificultad respiratoria (SDR) en recién nacidos prematuros (RNP), se realizó una revisión sistemática y meta-análisis. Métodos. Se incluyeron ensayos clínicos aleatorizados (ECA) donde se comparó SB con placebo. Las variables de desenlace fueron: mortalidad, morbilidad, días de ventilación mecánica (VM) y de estancia hospitalaria. Los ECA publicados hasta el 2010 se identificaron en Medline, EMBASE y la Colaboración Cochrane. La selección de los ECA fue por pares. En el meta-análisis se calculó riesgo relativo (RR) y diferencia de medias ponderada (DMP), con intervalos de confianza al 95% (IC95%). Resultados. De 865 títulos y resúmenes, se revisaron 89 artículos en extenso y se seleccionaron 12 ECA. El SB se mostró efectivo en cuatro variables: mortalidad (RR 0.73, IC95% 0.60-0.88, P =0.001), neumotórax (RR 0.41; IC95% 0.33-0.51, P <0.0001), enfisema intersticial pulmonar (RR 0.45; IC95% 0.36-0.56, P <0.0001) y días de VM (DMP -9.57; IC95% -16.58, -2.56, P =0.007). Para otras, como displasia broncopulmonar, enterocolitis necrosante, hemorragia intraventricular o alteración del desarrollo neurológico, no se determinó ventaja con SB. Conclusiones. En RNP, el uso de SB es efectivo al disminuir la mortalidad, la frecuencia de neumotórax y enfisema intersticial pulmonar, así como el tiempo de VM y, posiblemente, el de estancia hospitalaria.

Background. In order to evaluate the effectiveness of the bovine surfactant (BS) for the treatment of newborns with respiratory distress syndrome (RDS), we performed a systematic review and meta-analysis. Methods. Randomized-controlled trials (RCT) assessing the BS in comparison with placebo for the treatment of prematures with RDS were included. Outcome measures evaluated were: mortality, morbidity, days on mechanical ventilation (MV) and length of hospitalization. RCT published until 2010 were obtained from Medline, EMBASE and Cochrane Collaboration. Selection of included studies was based on a peer-review process. For the meta-analyses, relative risk (RR) and weighted mean differences (WMD) were calculated, with 95% confidence intervals (95%CI). Results. From 865 titles and abstracts obtained, 89 papers were reviewed and 12 RCT were selected. Among the outcome measures assessed, BS was shown to be effective in only in four: mortality (RR 0.73, 95% CI 0.60-0.88, p =0.001), pneumothorax (RR 0.41; 95% CI 0.33-0.51, p <0.0001), pulmonary interstitial emphysema (RR 0.45; 95% CI 0.36-0.56, p <0.0001) and on days of MV (WMD -9.57; 95% CI -16.58 to -2.56, p =0.007). However, we did not find any positive effect on bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage or abnormal neurological development. Conclusions. In newborns with RDS, bovine surfactant is effective regarding mortality, pneumothorax, and pulmonary interstitial emphysema, as well as on decrease in the length of MV and possibly on length of hospitalization.

Comparison of Synthetic Surfactant with Modified Bovine Surfactant in Neonatal Respiratory Distress Syndrome

PROPOSE: This study was designed to compare the efficacy of a synthetic surfactant (Exosurf) and a modified bovine surfactant (SurfactenR) in the treatment of neonatal respiratory distress syndrome. METHODS: A total of 90 infants with respiratory distress syndrome who were admitted to neonatal intensive care unit at Samsung Medical Center between October 1994 to September 1996 were includeeach surfactant. RESULTS: There was no significant difference in between two groups regarding birth weight, gestational age, and initiation of treatment after birth. ExosurfR group received less supplemental oxygen therapy and ventilator care. Survival rate were 81.3R in Exosurf group and 79.2% in SurfactenR group. The incidences of patent ctus arteriosus in the ExosurfR and SurfactenR groups were 75% and 62.5%, grade 3-4 intcular hemorrhage were 18.8% and 10.4%, respectively,' retinopathy of prematurity were 9.4% and 18.8%, respectively. There was significant improvernent of a/APO2 and VI at 30 minutes and 2 hours after the treatment in SurfactenR group', 2 hours and 6 hours after the treatment in ExosurfR group, however, dynamic compliance and respiratory resistance did not improve during 24 hours. CONCLUSION: Although SurfactenR treatment appears to induce faster improvement in oxygenation and pulmonary function than ExosurfR treatment, this study does not reveal any difference in clinical outcomes among those who received two different surfactant preparations.