Definition of analysis populations
The analysis population will comprise at least 1038 infants (as per the sample size calculation) randomized to either receive the intervention (budesonide mixed with surfactant) or control (surfactant alone).The intention-to-treat (ITT) population will include all randomized infants, regardless of exposure to the allocated treatment or adherence to the trial protocol, excluding infants who have been withdrawn from the trial. If a 