We searched the MEDLINE, CINAHL, and Cochrane Library databases for English-language randomized controlled trials, systematic reviews, and articles investigating surfactant replacement therapy published between January 1990 and July 2012. By inspection of titles, references having no relevance to the clinical practice guideline were eliminated. The update of this clinical practice guideline is based on 253 clinical trials and systematic reviews, and 12 articles investigating surfactant replacement therapy. The following recommendations are made following the Grading of Recommendations Assessment, Development, and Evaluation scoring system: 1: Administration of surfactant replacement therapy is strongly recommended in a clinical setting where properly trained personnel and equipment for intubation and resuscitation are readily available. 2: Prophylactic surfactant administration is recommended for neonatal respiratory distress syndrome (RDS) in which surfactant deficiency is suspected. 3: Rescue or therapeutic administration of surfactant after the initiation of mechanical ventilation in infants with clinically confirmed RDS is strongly recommended. 4: A multiple surfactant dose strategy is recommended over a single dose strategy. 5: Natural exogenous surfactant preparations are recommended over laboratory derived synthetic suspensions at this time. 6: We suggest that aerosolized delivery of surfactant not be utilized at this time.

http://rc.rcjournal.com/content/respcare/58/2/367.full.pdf

AARC Clinical Practice Guideline. Surfactant Replacement Therapy: 2013

/pdf/an-overview-of-acute-lung-injury-in-general-and-in-1h5gh1wpz2.pdf

An overview of acute lung injury in general and in particular viral infections with specific reference to nebulized surfactant and anticoagulation

Ten percent of all children are born preterm. Preterm birth increases the risk of death and diseases, among which chronic lung damage. In lung fluid of premature infants changes were found that can predict and partly explain lung damage. Furthermore, children were examined that were born after a uterus infection, main cause for preterm birth. There are indications that they can be better treated by raised dosage and more extensive application of medicines that are already used in practice. This can lead to a strong decrease of disease and death. It shows that early prediction of disease and specific treatment can contribute to a better future for premature infants.

/pdf/perinatal-modulators-of-respiratory-outcome-after-preterm-5blliiwv7q.pdf

Perinatal modulators of respiratory outcome after preterm birth

New Synthetic Surfactant Appears Safe and Effective

In our article,1 we reported the 1-year follow-up of preterm infants enrolled in 2 contemporaneous clinical trials that compared lucinactant, a peptide-containing synthetic surfactant, with colfosceril and animal-derived surfactants. The primary efficacy end points for these trials were described in their original publications.2,3 The primary conclusion from this 1-year follow-up was that lucinactant is at least as good as, if not superior to, animal-derived surfactants for prevention of respiratory distress syndrome. In response to this report, Lavin and Senn et al express concerns primarily related to our analytical approach to the data.Any retrospective analysis, be it a pooled patient-level analysis or a meta-analysis, can be biased, and we addressed the limitations of previously published meta-analyses4,5 in our article. Although variation in birth weight, gestational age, prenatal steroid use, and Apgar score in previously published meta-analyses is both substantial and clinically relevant, in our report these differences were slight and clinically unimportant. These trivial differences should reduce concerns about the validity of our report.We clearly described that the 1-year follow-up in both trials was planned before initiation and that all outcomes were prespecified. The study investigators remained blinded to 1 year corrected age. The aim of our article was to report those findings, the first such report among surfactant-comparison trials.The analytical approach in our 1-year follow-up was also prespecified, and additional analyses performed beyond the prespecified plan were clearly delineated in the article to avoid misleading the reader. Indeed, our approach would satisfy the rigorous regulatory standard quoted by Senn et al. However, publication in top-quality peer-review journals is the clinician's gold standard for guiding treatment decisions. Given the relevance and impact factor of Pediatrics, which also published the lucinactant trials, our reporting of these 1-year outcomes has met all standards.The time points chosen for the analyses were clinically relevant. The first 28 days after birth defines the newborn period, the saccular phase of normal lung development concludes at 36 weeks' gestational age, and infancy concludes at 1 year of age. Clinically, it is most helpful to present data to neonatologists in a way that is consistent with their considerations of the patient population for which they care. The 1-year corrected age time point provided a concrete and universally understood clinical milestone while also providing a reasonable period of follow-up when relative differences in the degree of lung health and overall well-being may affect survival. The fact that there were minimal (<2%) losses to follow-up at 1 year corrected age in both trials gives us substantial strength to affirm our conclusions.Interestingly, after criticizing our analyses, both Lavin and Senn et al provide their own retrospective interpretation, contradicting their early admonitions of such analyses to draw conclusions. In addition, Lavin suggests a pooled analysis, which requires more assumptions of the data than a meta-analysis. As suggested by Lavin and Senn et al, a logistic regression may be suitable when clinical milestones, such as 28-day survival, create landmark analyses. With a longer-term observation period such as a 1-year follow-up, a more sensitive and powerful time-to-event analysis such as survival analysis is the analysis of choice, even by regulatory agencies. Given patient-population characteristics in our studies, we used analytical methods that avoid bias in either direction and are most sensitive for identifying significant effects. The majority of deaths occur within 28 days after birth. Thereafter, the number of deaths out to 1 year corrected age is modest. Therefore, the Wilcoxon test provided, as Senn et al assert, an analysis that is sensitive to short-term differences and avoids bias on the basis of the small changes after the first 28 days after birth.Regarding the figures, we regret that there was an error in the original publication; however, a correction was subsequently published to correct this misprint.Statistical analyses of data from clinical studies are a means to understanding such data. Clinicians need to understand the degree to which study results can be applied to their scope of practice, and statistics allow them to judge whether these results are beyond mere random observations. In our 1-year follow-up, a numerically superior survival rate was observed for infants who were treated with lucinactant compared with those treated with beractant, poractant alfa, or colfosceril palmitate, with no difference in morbidity despite the proportionally higher number of survivors in the groups treated with lucinactant. Discussion of alternative statistical methods will not change this observation. Clinicians at the bedside are now left to decide how the results will affect their practice.

Meta-Analysis Combining 2 Previously Reported Trials on Respiratory Distress Syndrome in Neonates

A Multicenter, Randomized, Controlled Trial of Lucinactant Versus Poractant Alfa Among Very Premature Infants at High Risk for Respiratory Distress Syndrome

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A Multicenter, Randomized, Controlled Trial of Lucinactant Versus Poractant Alfa Among Very Premature Infants at High Risk for Respiratory Distress Syndrome