[2001] [2230] The Effect of Aquaphor Original Emollient Ointment on Nosocomial Sepsis Rates and Skin Integrity in Infants of Birth Weight 501 to 1000 Grams

William H. Edwards, Jeanette M. Conner, Roger F. Soll, for the Vermont Oxford Network Pediatrics, Dartmouth-Hitchcock Med Ctr, Lebanon, NH; Pediatrics, Univ of Vermont School of Medicine, Burlington, VT; Vermont Oxford Network, Burlington, VT

BACKGROUND: Poor skin integrity may be a factor in the increased risk for nosocomial infection noted in ELBW infants.
OBJECTIVE: To determine whether prophylactic application of Aquaphor ointment resulted in a lower incidence of death and/or nosocomial bacterial sepsis (NBS) in the first 28 days of life compared to routine skin care.
DESIGN/METHODS: Randomized controlled multicenter trial at 53 centers of the Vermont Oxford Network. Infants of birth weight 501-1000 gm and gestational age ≤30 wks who were expected to survive >48 hrs were stratified into two weight groups (501-750 gm, 751-1000 gm) and randomly assigned to receive generalized application of Aquaphor over the entire body twice a day through day 14 [Prophylactic group (P)] or PRN local application of Aquaphor to site of injury [Routine Skin Care (R)]. Of 1206 enrolled infants, 15 were excluded from final analysis.
RESULTS: Study groups (P=602, R=589) were comparable except that more infants in the prophylactic group received prenatal care (96.8% vs. 94.4%, p=0.04) and were male (54.3% vs. 47.3%, p=0.02). No difference was found in the combined primary outcome of NBS or death [33.6% P vs. 30.3% R, Relative Risk (RR) 1.16, 95% CI 0.91,1.49]. The incidence of death was no different between the groups (10.8% P vs. 12.1% R, RR 0.88; 95% CI 0.62,1.26). More infants in the prophylactic group had NBS (25.8% P vs. 20.4% R, RR 1.35; 95% CI 1.03,1.77), with the increase exclusively due to coagulase negative staphylococcus (CNS)(18.6% P vs. 13.3% R, RR 1.50; 95% CI 1.09,2.05). In the subgroup analysis, the increase in NBS was found only in infants 501-750 gms (28.9% P vs. 20.9% R, RR 1.54; 95% CI 1.04,2.30). Infants in the prophylactic group had better skin condition on days 1-14 of life and less skin injury days 15-28 of life. There was no difference between groups in the outcomes of fungal sepsis, or other complications of prematurity.
CONCLUSIONS: Prophylactic application of Aquaphor ointment did not lead to a difference in death and/or NBS in the first 28 days of life. NBS was more frequent in the prophylactic group, with the difference predominantly in the lower weight stratum (501-750 gm) and when CNS was the causal organism.
Funded in part by a grant from Beiersdorf, Inc.