Trial Status - Data Collection Complete

Phase One (February - July 2003): Participating Centers designated a Core Study Team to lead the trial and have completed the first phase of the trial. During this phase, Centers learned how to create an appropriate CPAP apparatus and were given materials about how to use nasal CPAP, how to apply nasal prongs, and how to troubleshoot difficulties in maintaining infants on nasal CPAP. These fundamental issues were reinforced using web conferencing. Each participating unit evaluated a minimum of 20 patients and completed data regarding problems encountered with the system,

Phase Two (August 2003 - May 2004): Phase II of this trial was very successful. We had over 100 infants enrolled with relatively few problems. In this pilot stage, units were randomizing infants to one of the three methods of delivery room stabilization. For different units, aspects of DR stabilization were more or less difficult. Some units have more experience with CPAP than with delivery room surfactant administration. Checklists regarding success of stabilizing infants and administration of assigned treatment and any post-treatment complications were monitored.

Phase Three (June 2004 - March 2009): Following the success of Phase II we began Phase III of this trial. Few protocol changes were necessary and centers, in general, complied with study assignment. However, fewer centers continued participation in the study. A total of 27 centers enrolled 658 infants over six years. For purposes of analysis, Phase II and Phase III will be combined.

The results of this study were presented at the Annual Meeting of Vermont Oxford Network in December 2009 and the Society for Pediatric Research in May 2010. A manuscript is forthcoming.