425 Early Endotracheal Instillation of Budesonide (B) Using Surfactant (SF) as a Vehicle to Preterm Infants at Risk for CLD¢WA Pilot Study

Abstract

Budesonide (B) undergoes an extensive biotransformation during the first pass metabolism in the liver to metabolites of low glucocorticoid activity. Surfactant (SF) (Survanta) can be used as a vehicle for B delivery in ventilated rabbits. Our previous study indicated that the addition of B to survanta (with ratio< =1:50) would not affect the surface tension property of surfactant. We therefore hypothesize that direct endotracheal installation of B and survanta would effectively deliver B into the lungs and would provide strong local anti-inflammation without much systemic side effects.Thirty-two infants (< = 1500 gm) with severe RDS who required IMV shortly after birth were randomly assigned into 2 groups: Gr. I (16) received SF (100 mg/kg) and B (0.5 mg or 2 ml/kg) and Gr. II (16) received SF (100 ml/kg) and saline (2 ml/kg). CLD was judged at 36 wks postconp. age. All infants were followed a standard protocol for resp. care.The two groups were comparable in BW, GA, perinatal characteristics and cardiopulmonary status on admission to NICU. Infants in Gr. I had significantly (P<0.05) higher PaO2 and lower OI on day 2, 3 and required less need of CPAP than Gr. II (mean ¡Ó S.D.; PO2 63 ¡Ó 25 vs 47 ¡Ó 18 mmHg and 62 ¡Ó 9 vs 43 ¡Ó 4 mmHg; OI 3.8 ¡Ó 0.7 vs 7.2 ¡Ó 2.4 and 3.6 ¡Ó 0.9 vs 6.3 ¡Ó 1.9; CPAP 2/16 vs 5/16). The incidence of CLD tends to be lower in Gr. I than Gr. II (4/16 vs 8/16). The two grs. were comparable in mortality (5/16 vs 4/16), in physical growth (BW, HL and HC), in blood pressure and serum glucose and in doses of surfactant administered (mean 1.8 vs 2.6 doses). We concluded that endotracheal instillation of surfactant + Budesonide improved pulmonary status without immediate side effects. This therapeutic regimen is warranted for further study.