Fig. 4

Protocol for the milrinone CDH study. Parents are approached for consent during either the antenatal period or the first 7 postnatal days. Once eligibility is determined based on presence of hypoxemic respiratory failure and meeting all the inclusion criteria and absence of any of the exclusion criteria, subjects are randomized to milrinone or placebo. Details of other modalities of treatment (alkalosis, surfactant), medications administered (including pulmonary vasodilator therapy, vasopressor therapy and postnatal steroids) are recorded. A baseline cranial ultrasound (#1) is obtained either prior to or within 4 h of study drug initiation. Randomization is performed within 12 h of establishing eligibility. The study drug should be initiated within 5 h of randomization. Maximum duration of study drug therapy is 72 h. Patient is monitored for adverse events (AE) 24 h after cessation of study drug. The criteria for triggering study drug wean/discontinuation are two oxygenation indices (OI) < 7 at least an hour or maximum 12 h apart. If arterial access is not available, oxygen saturation index (OSI) will be used to assess hypoxemia. Once weaning/discontinuation criteria are met, study drug should be weaned within 4 h. Open label milrinone can be initiated any time after completion of the study drug. Status form (including data on surgical details) will be collected at the end of the hospital course or at 120 days of postnatal age or death (whichever is earlier)