This trial was conducted in 53 centers in the Vermont-Oxford Network. Infants were enrolled at 501-1000 gm birth weight, EGA 30 weeks or less. All were enrolled before 48 hours of age. 1206 infants were randomized, 1191 completed the study. Primary outcome measures were nosocomial bacterial sepsis on or before 28 days and/or death on or before 28 days. A number of secondary outcomes were measured, including number of sepsis evaluations, fungal sepsis, meningitis, number of intubations, days of antibiotics or antifungals, weight at 7, 14, 21, 28 days, skin condition. Complications of prematurity, LOS, and mortality prior to discharge were also measured. Infants were randomized to receive bid applications of Aquaphor for 14 days, or "routine" skin care, defined as no emollient ointments or prn Aquaphor, providing that severity criteria were met. Infants were further stratified into birth weight categories: 501-750 gm and 751-1000 gm.

RESULTS: There were no demographic differences between the two groups. Interestingly, 33% of the "routine" group received some exposure to Aquaphor, likely because of skin irritation or breakdown. These infants received an average of 4.1 days of Aquaphor exposure, compared to 12.0 in the study group. There was no difference in the primary outcome of nosocomial sepsis OR death in the firs 28 days of life. Infants in the Aquaphor group had a significantly higher incidence of nosocomial sepsis prior to 28 days. This difference was due in large part to an increase in the incidence of coagulase negative Staph sepsis in the 500-750 gm group. Aquaphor significantly improved the "skin condition score" throughout the first 28 days of life, and significantly reduced the amount of "local skin injury" in the latter half of the study period. There were no differences in any of the other secondary outcome measures

Comment: The benefits of Aquaphor in the local care of the skin seem to occur from day 14-28. Local care differences may well have been higher had not 33% of the control infants received some Aquaphor therapy. The study protocol did not allow evaluation of the benefits, if any, of the reduction in transepidermal water loss (TEWL) in the Aquaphor group. The question of how to interpret the difference in sepsis rates between the two groups is much more difficult. The critics of Aquaphor use will no doubt claim vindication, while the supporters will be quick to point out that the difference barely reaches significance. In a study characterized by such homogeneity of results, might this difference be the 1 in 20 (5%) which really are due to chance alone. It will be interesting to read the published report, and to see what effect this study will have on our clinical practice.

Griffith E. Quinby M.D.