Original ArticleRandomized Controlled Trial of Lung Lavage with Dilute Surfactant for Meconium Aspiration Syndrome
Section snippets
Methods
This was an international multicenter randomized controlled trial of dilute surfactant lavage in MAS, approved by institutional ethical review committees, national ethical review committees, or both. Participating centers (n = 20) were tertiary level neonatal intensive care units, each equipped with standard therapeutic modalities for MAS, including HFOV and iNO. Half the participating centers had access to ECMO. A training workshop was conducted at each center, including a simulation of lavage
Results
The numbers of infants screened, eligible for inclusion, excluded, and randomized are shown in Figure 2. Of 328 infants ventilated with MAS during the study period, 118 (36%) met inclusion criteria, with 12 excluded on the basis of cardiorespiratory instability (Figure 2). The 66 infants were enrolled from 13 participating centers (Appendix). Demographic and clinical characteristics of the two groups were similar at the time of randomization (Table I). All infants were from singleton
Discussion
MAS is a serious newborn respiratory disorder for which there is a frustrating lack of specific therapy.1 In this study, we examined the impact of lung lavage in MAS, with a technique developed in a series of laboratory experiments14 and evaluated in a preliminary study in ventilated infants.22 We found no evidence for an effect of lavage on duration of respiratory support, but there appeared to be a reduction in mortality, especially when infants ostensibly saved with ECMO were considered with
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Cited by (0)
Supported by grants from the Australian National Health and Medical Research Council (284539 and 384100) and the Murdoch Childrens Research Institute. Abbott Pty Ltd. provided surfactant for lavaged infants. The funding sources had no role in the study design, data collection, data analysis, or preparation of the report. The authors declare no conflicts of interest.
This trial is registered with the Australia and New Zealand (Clinical Trial Register #12606000290594).
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List of members of the lessMAS Trial Study Group is available at www.jpeds.com (Appendix).