Abstract 1162 Clinical Trials in Perinatal Neonatal Medicine Platform, Tuesday, 5/4

Purpose: This four-center randomized trial aimed to determine if a 3-day course of DT beginning at 24-48 hours of life would improve survival without CLD in ventilated, high-risk neonates.

Methods: From 1992-1997, 241 neonates (DT=118; Placebo [P]=123) who: weighed between 500-1500 grams, received surfactant therapy, and were at significant risk for CLD at 24 hours of lifeFootnote 1 were randomized by birth weight and initial a/A ratio prior to surfactant to receive either 6 doses of DT (0.25mg/kg×4, 0.125mg/kg, 0.05mg/kg) at 12-hour intervals or P. The primary outcome was survival without CLD at 36 weeks. Secondary outcomes (LOS, ventilator and FIO2 days, subsequent dexamethasone), morbidities (PVL, PIVH) and adverse effects of DT (sepsis, intestinal perforation [IP], weight gain) were also compared. Results: DT and P neonates enrolled were similar with respect to antenatal steroid exposure, GA (26±0.2 vs 26.1±0.2 weeks), and SNAP score (p>0.2). Primary Outcome: Survival without CLD was greater in DT neonates (70% vs 58%, RR 1.3, CI 1.03-1.07). Mortality was similar (16% DT, 20% P, p=0.3). Differences in survival without CLD were most apparent in neonates ≤1000 grams with severe (a/A≤0.15) lung disease (62% DT vs 33% P, p=0.02). Secondary Outcomes: A subsequent course of dexamethasone was less common in DT neonates (69% vs 83%, RR 0.8, CI 0.7-0.9) and they spent less days in FIO2 (median days 43 vs 50, p=0.04). Ventilator days and length of stay were similar (p≥0.2) Morbidities and Adverse DT Effects: Any PIVH (36% vs 52%) and PDA ligation (14% vs 28%, p=0.01) was less common in DT neonates (p=0.02). PVL rates did not differ (p=0.8). Early (≤14 days) septicemia and 28-day weight gain did not differ (p≥0.2). IP during the first week of life was more common in DT neonates (8% vs 1%, p=0.009). Hypertention and insulin therapy was more common among DT neonates (p≤0.007). Conclusion: An early 3-day DT course for high-risk ventilated neonates increases survival without CLD, especially in neonates with severe lung disease. Benefits of early DT need to be weighed against risk of early IP and other adverse effects of DT.