The Effect of Prophylactic Ointment Therapy on Nosocomial Sepsis Rates and Skin Integrity in Infants With Birth Weights of 501 to 1000 g
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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 < or =30 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.
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