Abstract

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 less than or equal to 30 wks who were expected to survive more than 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) 1.10, 95% CI 0.94,1.31]. The incidence of death was no different between the groups (10.8% P vs. 12.1% R, RR 0.89; 95% CI 0.65,1.23). More infants in the prophylactic group had NBS (25.8% P vs. 20.4% R, RR 1.26; 95% CI 1.02,1.56), with the increase exclusively due to coagulase negative staphylococcus (CNS)(18.6% P vs. 13.3% R, RR 1.40; 95% CI 1.08,1.83). In the subgroup analysis, the increase in NBS was found only in infants 501-750 gms (28.9% P vs. 20.9% R, RR 1.60; 95% CI 1.07,2.39). 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.