A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome

Malloy, Colleen Ann; Nicoski, Pamela; Muraskas, Jonathan

doi:10.1080/08035250510028740

Cited by 45 publications

(60 citation statements)

References 25 publications

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“…This is a highly selected population of very premature infants who were mechanically ventilated for RDS, infants with the greatest risk of developing the morbidities of prematurity, including PDAs and chronic lung disease. Our observation extends the findings of Malloy et al 5 who also found a lower incidence of PDAs in infants treated with poractant alfa, compared with beractanttreated infants.…”

Section: Discussionsupporting

confidence: 91%

Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome

et al. 2010

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Objective: Respiratory distress syndrome (RDS), requiring mechanical ventilation and exogenous surfactant treatment, and patent ductus arteriosus (PDA), are common co-morbidities in very premature infants. The effects of intra-tracheal surfactant administration on the cardiovascular and pulmonary systems in very premature infants with RDS and PDAs are not well characterized. We evaluated the effects of poractant alfa and beractant, surfactants with different rapidity of onset and duration of action, in very premature infants with RDS. To assess whether there were differences in PDA hemodynamics in very premature infants with RDS treated with poractant alfa and beractant during the first week of life and to assess whether poractant alfa or beractant had a direct effect on PDAs and PDA hemodynamics following the second dose of surfactant.Study Design: We studied 50 in-born, very premature infants with RDS, 24 0 of 7 to 29 6 of 7 weeks gestation, treated with poractant alfa or beractant, in an open label, 1:1, randomized clinical trial. A subgroup of 16 patients with severe RDS, treated with a second dose of surfactant, had echocardiographical assessments before and 20 to 30 min after the second dose of surfactant.Result: There were 25 infants treated with poractant alfa (27.1 ± 1.6 weeks, birth weight 930±231 g) and 25 treated with beractant (26.7 ± 1.7 weeks, P ¼ 0.407 and birth weight 898 ± 282 g, P ¼ 0.666). Clinically significant PDAs were diagnosed and treated in 8 of 25 (32%) of the poractant alfa and 19 of 25 (76%) of the beractant group (P ¼ 0.002). Indomethacin treatment was slightly earlier (3.4 ± 2.5 days) in the poractant alfa than in the beractant group (5.1±4.9 days, P ¼ 0.038). Right ventricle pressure (RVP)/systolic arterial pressure (SAP) ratio in the first week was slightly lower in the poractant alfa (64±20%) than in the beractant (78 ± 26%, P ¼ 0.048) group. Following a second dose of surfactant, neither poractant alfa nor beractant changed PDA flow. These hemodynamic observations were associated with less respiratory support in the poractant alfa group, allowing earlier extubation (13 of 25 at 48 h and 15 of 25 at 72 h), than in the beractant group (6 of 25 at 48 h, P ¼ 0.044, and 8 of 25 at 72 h, P ¼ 0.049). Conclusion:The more rapid improvement in pulmonary function in the poractant alfa-treated infants was associated with a lower RVP/SAP ratio and a corresponding earlier treatment with indomethacin. Neither surfactant had a significant direct effect on PDA hemodynamics. The lower frequency of clinically significant PDAs in the poractant alfa compared with the beractant group may represent an indirect effect of the differences in the pulmonary improvement induced by the two surfactants.

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Section: Discussionsupporting

confidence: 91%

Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome

et al. 2010

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“…In the study by Ramanathan et al 27 both doses of poractant alfa (100 mg kg À1 and 200 mg kg À1 ) were compared with one dose of beractant (100 mg kg À1 ) and neonatal mortality was lowest in the higher dose poractant alfa group (3%) versus lower dose poractant alfa (6%) and beractant (8%). Similar reductions in mortality have been found in other trials that used a 200 mg kg À1 initial dose 32,33 (Table 3). If the Ramanathan et al study is taken to report two separate trials, beractant versus two groups of poractant alfa-treated infants, then six comparative trials of these two natural surfactants can be considered with a total of 20 deaths in the poractant alfa group and 33 in the beractant group (Table 3).…”

supporting

confidence: 85%

Surfactants: past, present and future

2008

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In 1929 Kurt von Neergaard performed experiments suggesting the presence of pulmonary surfactant and its relevance to the newborn's first breath. Almost 25 years later, Richard Pattle, John Clements and Chris Macklin, each working on the effects of nerve gases on the lungs, contributed to the understanding of the physiology of pulmonary surfactant. About 5 years later Mary Ellen Avery and Jere Mead published convincing evidence that preterm neonates dying of hyaline membrane disease (respiratory distress syndrome, RDS) had a deficiency of pulmonary surfactant. The first trials of nebulized synthetic (protein-free) surfactant to prevent RDS were published soon after Patrick Bouvier Kennedy (son of President John F Kennedy) died of this disorder after treatment in Boston. These trials were unsuccessful; however, Goran Enhorning and Bengt Robertson in the early 1970s demonstrated that natural surfactants (containing proteins) were effective in an immature rabbit model of RDS. Soon after this Forrest Adams showed that a natural surfactant was also effective in an immature lamb model. Working with him was Tetsuro Fujiwara who 2 years later, after returning to Japan, published the seminal article reporting the responses of 10 preterm infants with RDS to a bolus of modified bovine surfactant. During the 1980s there were numerous randomized controlled trials of many different natural and synthetic surfactants, demonstrating reductions in pulmonary air leaks and neonatal mortality. Subsequently natural surfactants were shown to be superior to the protein-free synthetic products. Recently there have been a number of randomized trials comparing different natural surfactant preparations. Commercially available bovine surfactants may have similar efficacy but there is some evidence that a porcine surfactant used to treat RDS with an initial dose of 200 mg kg À1 is more effective than a bovine surfactant used in an initial dose of 100 mg kg -1 . Bovine and porcine surfactants have not been compared in trials of prophylaxis. Very recently a new synthetic surfactant with a surfactant protein mimic has been compared with other commercially available natural and synthetic surfactants in two trials. The new surfactant may be superior to one of the older protein-free synthetic surfactants but there is no evidence of its superiority over established natural products and it is currently not approved for clinical use. A number of other new synthetic surfactants have been tested in animal models or in treatment of adults with ARDS, but so far there have been no reports of treatment of neonatal RDS. Natural surfactants work best if given by a rapid bolus into the lungs but less invasive methods such as a laryngeal mask, pharyngeal deposition or rapid extubation to CPAP have showed promise. Unfortunately, delivery of surfactant by nebulization has so far been ineffective. Surfactant treatment has been tried in a number of other neonatal respiratory disorders but only infants with meconium aspiration seem to benefit although larger and mo...

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“…In a meta-analysis of the two studies 23,25 comparing beractant vs poractant alfa, neonatal mortality was significantly lower with poractant alfa (odds ratio 0.35, 95% CI 0.13, 0.92). In a recent study comparing these two surfactants, Malloy et al 26 extended the observations of Ramanathan et al 25 They showed improvement in oxygenation to persist up to 48 h ( Figure 1) 26 after treatment with poractant alfa, and a significantly lower number of additional doses with poractant alfa compared to beractant. It is also interesting to note that the use of a higher initial dose of poractant alfa at 200 mg/kg vs 100 mg/kg of beractant in three comparison trials have consistently shown a lower mortality favoring poractant alfa (Figure 2).…”

Section: Introductionmentioning

confidence: 64%

“…It is also interesting to note that the use of a higher initial dose of poractant alfa at 200 mg/kg vs 100 mg/kg of beractant in three comparison trials have consistently shown a lower mortality favoring poractant alfa (Figure 2). 23,25,26 This observation may have been due to a larger dose of a more effective surfactant moderating disease severity during the acute phase of RDS in these ill preterm infants, thus resulting in a better survival. However, none of these trials was powered to evaluate mortality as a primary outcome.…”

Section: Introductionmentioning

confidence: 99%

Surfactant therapy in preterm infants with respiratory distress syndrome and in near-term or term newborns with acute RDS

Ramanathan

2006

J Perinatol

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Many different surfactant preparations derived from animal sources, as well as synthetic surfactants, are available for the treatment of preterm infants with respiratory distress syndrome (RDS). Natural, modified surfactants containing surfactant-associated proteins appear to be more effective than non-protein-containing synthetic surfactants. Comparative trials with poractant alfa at a higher initial dose of 200 mg/kg appear to be associated with rapid weaning of FiO 2 , less need for additional doses, and decreased mortality in infants <32 weeks gestation when compared with beractant. Early rescue (<30 min of age) surfactant therapy is an effective method to minimize over treatment of some preterm infants who may not develop RDS. Surfactant therapy followed by rapid extubation to nasal ventilation appears to be more beneficial than continued mechanical ventilation. In near-term or term newborns with acute RDS, surfactant therapy has been shown to be 70% effective in improving respiratory failure.

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A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome

Cited by 45 publications

References 25 publications

Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome

Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome

Surfactants: past, present and future

Surfactant therapy in preterm infants with respiratory distress syndrome and in near-term or term newborns with acute RDS

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