Abstract 1365 Clinical Trials in Perinatal Neonatal Medicine Platform, Tuesday, 5/4

Background: Many extremely low birth weight infants (<1000 g) show biochemical evidence of adrenal insufficiency in the first week of life, correlating with subsequent development of chronic lung disease (CLD). Methods: We conducted a randomized, double-masked, placebo-controlled pilot study to test whether early treatment with low-dose hydrocortisone (1.0mg/kg/day × 0.5mg/kg/day for 3 days) begun before 48 hours of life, would increase the likelihood of survival without chronic lung disease. Results: Forty patients were enrolled at two centers. Birth weight and gestation were similar for treatment and placebo groups: 732±135 grams v 770±135 grams; 25.2±1.3 weeks v 25.4±1.5 weeks. More infants treated with hydrocortisone (HC) achieved study success, defined as survival without supplemental oxygen at 36 weeks postconception (12/20 (60%) v 7/20 (35%); p=0.023 by logistic regression). Lower birth weight, histologic chorioamnionitis and preeclampsia were significant risk factors, whereas study center, prenatal steroids, sex, and ethnicity were not significant. Hydrocortisone treatment decreased days on > 40% oxygen (median[25-75%ile] 7[3-18] vs 28[10-51], p=0.006), days on >25% oxygen (48[32-64] vs 69[34-75],p=0.02), days on ventilator (25[14-34] vs 32[11-45],p=0.03), and oxygen at discharge (24% vs 47%, p=0.04). Among infants exposed to chorioamnionitis, hydrocortisone treatment was also associated with increased enteral intake during the first month of life and with increased weight at 36 weeks postconception (mean±SD 2072±87g vs 1815±215, p=0.03). Five treated infants and six placebo infants developed sepsis; three in each group died. Conclusions: (1) Early treatment with low-dose hydrocortisone in this population of extremely low birth weight infants increased the likelihood of survival without chronic lung disease. (2) Benefit was particularly apparent in infants with chorioamnionitis. (3)A larger multicenter trial is needed to verify the primary outcome and better evaluate risks and benefits.