OBJECTIVE: To determine whether extremely low birth weight infants who receiveenteral sterile water have a reduction in treated patent ductus arteriosus or death by 28 days compared to infants with routine management. STUDY DESIGN: A total of 214 infants were enrolled and randomized by 36 h of age to receive up to 50 ml kg(-1) per day of enteral sterile water (n=109) for 7 days or routine fluid management (n=104). Patent ductus arteriosus treatment was defined as either indomethacin treatment or surgical ligation. RESULT: The proportion of infants with a treated patent ductus arteriosus or death at <28 days of age was 63% in the sterile water group vs 64% in the control group (relative risk 0.99, 95% confidence interval 0.81 to 1.22). There were no differences in the proportion of infants in the sterile water group vs control group with a treated patent ductus arteriosus (55 vs 48%), death (21 vs 28%), necrotizing enterocolitis or death (24 vs 32%), or bronchopulmonary dysplasia or death at <28 days (80 vs 77%). Daily mean glucose levels were significantly higher (P=0.04) in control infants than sterile water infants. CONCLUSION: The use of sterile water did not decrease the incidence of patent ductus arteriosus or other adverse clinical outcomes. The role of enteral sterile water in the fluid management of extremely low birth weight infants remains uncertain.
RCT Entities:
OBJECTIVE: To determine whether extremely low birth weight infants who receive enteral sterile water have a reduction in treated patent ductus arteriosus or death by 28 days compared to infants with routine management. STUDY DESIGN: A total of 214 infants were enrolled and randomized by 36 h of age to receive up to 50 ml kg(-1) per day of enteral sterile water (n=109) for 7 days or routine fluid management (n=104). Patent ductus arteriosus treatment was defined as either indomethacin treatment or surgical ligation. RESULT: The proportion of infants with a treated patent ductus arteriosus or death at <28 days of age was 63% in the sterile water group vs 64% in the control group (relative risk 0.99, 95% confidence interval 0.81 to 1.22). There were no differences in the proportion of infants in the sterile water group vs control group with a treated patent ductus arteriosus (55 vs 48%), death (21 vs 28%), necrotizing enterocolitis or death (24 vs 32%), or bronchopulmonary dysplasia or death at <28 days (80 vs 77%). Daily mean glucose levels were significantly higher (P=0.04) in control infants than sterile waterinfants. CONCLUSION: The use of sterile water did not decrease the incidence of patent ductus arteriosus or other adverse clinical outcomes. The role of enteral sterile water in the fluid management of extremely low birth weight infants remains uncertain.