49 Prophylaxis of Chronic Lung Disease with Low-Dose Hydrocortisone: A Randomised, Placebo Controlled Trial. Preliminary Report

BACKGROUND Several reports showed decreased cortisol response to adreno-corticotropic hormone in preterms developing chronic lung disease (CLD). Administration of prophylactic low-dose hydrocortisone (HC) may allow for beneficial effects, particularly in infants with histologic chorioamnionitis. However, there are concerns regarding short and long-term effects of corticosteroid therapy in preterms. OBJECTIVE Evaluation of effectiveness and safety of prophylactic HC in improving survival without CLD in preterms. METHODS Double blind randomised placebo-controlled trial in 2 centres. After parental consent mechanically ventilated infants (birth weight 500-1249) were entered within 48 hours of life and randomized to receive treatment (HC: 0,5 mg/Kg/12 hrs for 9 days, then 0,5 mg/Kg/ 24 hrs for 3 days) or placebo for 12 days. The major outcome was assessed as survival without CLD (oxygen dependency at 36 weeks of postmenstrual age). The protocol was approved by Ethical Committee at each institution and notified to the National Observatory on Human Drug Experimentation. RESULTS 41 patients were enrolled since April 2003. Birth weight, gestational age, chorioamnionitis, CRIB and FiO2 requirements at entry were similar between the two groups. Survival without CLD was 61% in HC group versus 30% in controls (p<0.05). Mortality rate was 22% in HC group vs. 43% in controls (p=ns). Chorioamnionitis occurred in 51% of patients. In chorioamnionitis group survival without CLD was 42% in HC group vs. 16% in controls (p=ns). Incidence of sepsis, IVH, PVL, NEC, ROP, PDA, hyperglycaemia, hypertension, gastrointestinal perforation, head circumference and weight at 36 weeks were similar between the two groups. Hyperkalemia in the HC group was significantly higher. DISCUSSION HC prophylaxis improved survival without CLD in our population, without important short term effects. Neurodevelopmental outcomes will be assessed at 2 years.