Commentary on: Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants (28 + 0 to 34 + 6 Week) With Respiratory Distress Syndrome: A Randomized Controlled Trial

We would like to commend the authors for executing a study we wish we had done. Surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) has been shown to reduce mortality and associated complications. Bovine lipid extract surfactant (BLES) was developed in Canada in the early 1980s and has been the most widely used preparation in the country for decades. Production and distribution costs are relatively low and BLES remains one of the most economical of the commercially available surfactant preparations. Poractant alfa (Curosurf) is the most widely used surfactant in most other countries and European guidelines recommend that it be used to treat intubated babies with confirmed RDS [1]. Comparative studies with various bovine surfactant preparations suggest that there may be an advantage to using Curosurf at the recommended initial high dose of 200 mg/kg [2]. Curosurf was introduced into Canada in 2017 and clinicians were uncertain as to whether a change to routine practice might be indicated. We did not have the resources to conduct a large randomized trial comparing the two surfactants, so our group conducted a small RCT at three centers [3] and followed it with a comparative effectiveness trial involving most of the NICUs in Canada [4]. In both studies, BLES and Curosurf seemed to have similar efficacy and safety profiles when treating intubated premature infants with RDS. However, few infants were treated using LISA/MIST which has since become the recommended standard approach for babies with RDS initially managed with noninvasive respiratory support. While poractant alfa has been used in most trials assessing LISA, a small trial from Canada showed that BLES could be used for LISA with good treatment success in spite of the larger volume instilled and lower total phospholipid dosing provided when compared to poractant alfa [5]. RDS is the most common cause of neonatal death in preterm infants born in low and middle-income countries (LMICs). Treatments for these infants include provision of basic supportive care, application of continuous positive airway pressure, administration of exogenous surfactant and in some cases, use of mechanical ventilation [6]. Each of these therapeutic measures is expected to improve survival incrementally when applied to the management of preterm infants in healthcare settings. While basic supportive care and CPAP have become standard in most LMICs, surfactant is not universally available, and when available, may not be used because of prohibitive cost. Costs are not usually covered by government health authorities, and families may be required to pay for it out of pocket or forego treatment if they cannot afford it. One vial of surfactant can cost as much as a month's salary in some settings. An affordable surfactant preparation for use in LMICs is required for optimal uptake and benefit to be appreciated. This study from Zamal et al. reports on a study designed to answer a clinically very pertinent question: what is the comparative efficacy and cost-effectiveness of BLES versus poractant alfa when administered via the LISA technique in moderately preterm infants with RDS [7]. The authors performed a well-designed, single-center, randomized controlled trial, which included 282 moderately (28−34 weeks) preterm infants, who were less than 6 h post-birth with respiratory distress requiring noninvasive respiratory support and at least 30% oxygen. They observed no clinically significant differences in the need for intubation or time on invasive or noninvasive respiratory support, nor for any usual prematurity-related predischarge complications or mortality. The total surfactant cost was 30% lower in the BLES group: the authors conclude that “BLES's significant cost advantage makes it a compelling choice for resource-limited settings.” While the results of this study should make clinicians comfortable in choosing BLES to treat preterm babies when using the LISA technique, we suggest the next step to be a multicenter, international study examining this question. Such a study should include extremely preterm infants, where the LISA technique is being used more and more. Ultimately, an effective synthetic surfactant preparation that can be mass-produced at low cost would be expected to be the best solution to the limited access currently impacting preterm babies with RDS in resource-limited settings. Brigitte Lemyre: writing – review and editing. Michael Dunn: writing – review and editing. The authors declare no conflicts of interest. The authors have nothing to report.

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