The effect of prophylactic ointment therapy on nosocomial sepsis rates and skin integrity in infants with birth weights of 501 to 1000 g

Objective. Extremely low birth weight infants have a high risk of developing nosocomial bacterial sepsis (NBS). Immature fragile skin may represent an inadequate protective barrier to bacteria colonizing the skin. We conducted a randomized, multicenter trial to determine whether prophylactic application of an emollient ointment would result in a lower incidence of death and/or NBS in the first 28 days of life, compared with routine skin care. Methods. Infants of birth weight 501 to 1000 g and gestational age less than or equal to30 weeks were assigned randomly to receive generalized application of ointment twice a day through day 14 (prophylactic group [P]) or local application of ointment to the site of injury ( routine skin care [R]). The study was conducted at 53 neonatal intensive care units that were members of the Vermont Oxford Network. Results. Included in the analysis were 1191 infants (P: 602; R: 589). No difference was found in the combined primary outcome of NBS or death (33.6% P vs 30.3% R; relative risk [RR]: 1.10; 95% confidence interval [CI]: 0.89, 1.27). The incidence of death was no different between the groups (10.8% P vs 12.1% R; RR: 0.87; 95% CI: 0.59, 1.25). More infants in the prophylactic group had NBS (25.8% P vs 20.4% R; RR: 1.26; 95% CI: 1.02, 1.54), predominantly in the lower birth weight infants (501-750 g) and for infections caused by coagulase-negative staphylococci. Infants in the prophylactic group had better skin condition on days 1 to 14 of life and less skin injury on days 15 to 28 of life. There was no difference between groups in other complications of prematurity. Conclusions. Prophylactic application of ointment did not lead to a difference in death and/or NBS in the first 28 days of life. There may be an increase in the risk of NBS associated with this practice.