Limitations
IVH
EPP, BRONCHOPULMONARY DYSPLASIA, NECROTIZING ENTEROCOLITIS, COMPLICATIONS
Our EXPLAIN study has several limitations. First, restricting a study to participants giving prenatal consent may limit external validity because mothers who were not approached were in advanced labor. Thus, a large proportion of infants at a higher risk of neonatal complications may not have been enrolled, also resulting in a relatively old patient population. Second, this was a monocentric trial comprising 60 infants in a center with long experience in EPP and a different strategy of respiratory support during neonatal resuscitation based on titration of high continuous airway pressures rather than the use of positive pressure ventilation. Therefore, our findings regarding feasibility may not be generalizable to other settings.Another important limitation of our trial is that we did not calculate sample size with regard to safety aspects of the EPP procedure. Therefore, our study did not have sufficient power to conclude with certainty that these 2 interventions were interchangeable with respect to adverse maternal and neonatal outcomes in the short and long term. Given that the incidence of major neonatal complications, such as bronchopulmonary dysplasia, IVH, or necrotizing enterocolitis, is low in our center, a higher number of participants may be needed to detect significant differences in these outcome variables. In this context, further multicenter trials are mandatory to determine feasibility and reproducibility in other centers less experienced with EPP.