Our previously published manuscript described an attempted multicenter randomized trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants [1]. Eligibility criteria included ≥34 weeks gestation at birth, <48 h postnatal age, intubated and mechanically ventilated, and receiving an inotrope for a diagnosis of cardiovascular insufficiency. Infants were randomized to 7 days of hydrocortisone, tapered from an initial dose of 2 mg/kg/day, or placebo. Because death or neurodevelopmental impairment (NDI) at 2 years was considered a more significant outcome than any short-term measure such as length or total dose of inotropic therapy, we chose this as the primary study outcome and excluded those at high risk for NDI. Unfortunately, this led to exclusion of 207 of 257 otherwise eligible infants, including those with major congenital anomaly or chromosomal disorder other than heart disease (n = 100), hypoxic-ischemic encephalopathy qualifying for hypothermia therapy (58), congenital heart disease (35), and receipt of open-label glucocorticoid therapy (33). As a result of these exclusions, only 12 infants were randomized over 10 months; therefore, the study was terminated for futility of enrollment. Neonatal diagnoses (more than one per patient) included respiratory distress syndrome (n = 8), pneumothorax and/or pneumomediastinum (2), meconium aspiration syndrome (7), pneumonia (1), pulmonary hypertension (5), and necrotizing enterocolitis (1). Mean gestational age was 38.4 ± 2.2 weeks and birth weight 3267 ± 600 g, similar between groups. Days of inotrope exposure did not differ between groups. Mean maximum inotrope dose was 9.5 ± 2.9 mcg/kg/min in the HC-treated group and 14.7 ± 12.6 mcg/kg/min in the placebo-treated group.
This research letter reports the 2-year outcomes for these patients. One was lost to follow up; 11 were seen at age 2 and evaluated with the Bayley Scales of Infant Development III (BSID-III), the gross motor function scale, and neurologic examination. Although this number is certainly too small to evaluate any effect of hydrocortisone therapy, we herein briefly summarize their outcomes at age 2. None of the infants died. Three in each group were diagnosed with NDI, defined in the protocol as “any hearing impairment or visual impairment, non-normal gross motor function level, seizures, or a cognitive, language, or motor score of the BSID-III >1 standard deviation below the average”. Of those, four children had BSID-III scores <85 (including one <70), one had seizures, one had bilateral vision impairment. The small number limits any conclusions regarding outcomes of cardiovascular insufficiency in late preterm and term infants, but the presence of NDI in 6/11 infants at follow-up emphasizes the need to follow these infants. Full details on their primary and secondary outcomes are available in clinicaltrials.gov (#NCT01954056).
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