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Conner JM, Soll RF, Edwards WH. Topical ointment for preventing infection in preterm infants. Cochrane Database Syst Rev. 2004;(1):CD001150.
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Edwards WH, Conner JM, Soll RF; for the Vermont Oxford Network. The effect of Aquaphor original emollient ointment on nosocomial sepsis rates and skin integrity in infants of birth weight 501 to 1000 grams [abstract]. Pediatr Res.
2001;49:388A.
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A Cochrane Review assessed the effects of routine prophylactic application of topical ointment on the rate of nosocomial sepsis and other complications associated with prematurity. Studies included were randomized, controlled trials comparing prophylactic application with either routine skin care or a topical ointment to manage dermatitis. Patients enrolled were <37 weeks’ gestation and treatment began within 96 hours of birth. Outcome measures included sepsis diagnosed by either a single positive blood or cerebrospinal fluid (CSF) culture.
Infections in the original publications were stratified into the following groups for the purposes of reporting and analysis: (1) bacterial with known pathogen, other than coagulase-negative staphylococcus (CoNS), after 2 days of life; (2) CoNS or Staphylococcus epidermidis infection; (3) infection with any pathogenic bacteria (an aggregate measure, including CoNS and S. epidermidis); (4) any fungal infection; and (5) any nosocomial infection, including any bacterial or fungal organism. Recorded complications of prematurity included patent ductus arteriosus, bronchopulmonary dysplasia, chronic lung disease, and mortality. Overall, 4 trials satisfied the criteria for inclusion and 4 did not.
All studies included treatment with a topical ointment twice daily. Lane and Drost31 randomized 34 neonates between 29 and 36 weeks’ gestation to either the treatment or to routine skin care. Assessment of skin condition, fungal cultures, and quantitative bacterial cultures were performed twice weekly.31 Nopper and colleagues34 randomized 60 neonates at <33 weeks’ gestation. Data collection included temperature, TEWL, fluid intake, weight, skin condition, surveillance skin cultures, and blood and CSF cultures, as needed.34 Pabst and associates35 randomized 19 preterm neonates between 26 and 30 weeks’ gestation. Skin condition, fluid requirements, and skin surveillance cultures were monitored.35
In this large, multicenter trial, 1191 neonates with birth weights from 501 to 1000 grams were studied. Mortality, proven and suspected sepsis, skin condition, weight, and other complications of prematurity were measured.
All studies reported data on bacterial infections with a known pathogen other than CoNS. Meta-analysis revealed no difference in risk among infants receiving prophylactic emollient skin care compared with control infants (typical relative risk [RR], 0.90; 95% confidence interval [CI], 0.63, 1.29; typical risk difference, -0.01; 95% CI, -0.04, 0.02).
Risk for infection from CoNS was also measured, with inconsistent findings. Smaller studies by Lane and Drost31 and Pabst et al.35 documented increased, although insignificant, risk in the treatment group, whereas Nopper et al.34 reported decreased risk in the prophylactic ointment group. In the latter study, 8 infants in the control group acquired CoNS, compared with 1 in the treatment group (RR, 0.13, 95% CI, 0.02, 0.94). By contrast, the large trial had sufficient power to demonstrate increased risk (RR, 1.40; 95% CI, 1.08, 1.83). Meta-analysis including all trials documented a significantly increased risk for CoNS infection in the treatment group compared with the control group (typical RR, 1.31; 95% CI, 1.02, 1.70; typical risk difference, 0.04; 95% CI, 0.00, 0.08).
The study by Edwards et al., as well as a study by Lane and Drost,31 reported increased risk in the treatment group for any bacterial infection. Findings from the smaller studies by Nopper et al.34 and Pabst et al.35 reported reduced risk for any bacterial infection in the treatment group and did not identify risk for any bacterial infection. Meta-analysis of the 4 original trials did identify a trend toward risk for any bacterial infection in the treatment group (typical RR, 1.19; 95% CI, 0.97, 1.46; typical risk difference, 0.04; 95% CI, -0.01, 0.08).
Two of the studies, by Lane and Drost31 and Nopper et al.34 documented no fungal infections in either group. Pabst and coworkers35 reported a nonsignificant reduction in the treatment group, whereas Conner and Edwards reported a nonsignificant increase. Data on fungal infections showed no significant difference among the groups.
When all nosocomial infections (bacterial or fungal) were considered, meta-analysis showed an increased risk in the treatment group (typical RR, 1.20; 95% CI, 1.00, 1.43; typical risk difference, 0.05; 95% CI, 0.00, 0.09). The meta-analysis for all other complications of prematurity, including patent ductus arteriosus, bronchopulmonary dysplasia, chronic lung disease, and mortality, showed no significant difference between the treatment and control groups.
All studies reported improved skin condition with twice-daily application of topical emollient ointment. However, the RR for CoNS infection rose 31% and the RR for any nosocomial infection (bacterial or fungal) rose 20% in treated infants. The mechanism by which infection increased is unclear, and methods of dispensing and administering ointment varied and were inconsistently reported. Contamination might have occurred, and the ointment might have provided an environment conducive to bacterial overgrowth on fragile, immature skin. Thus, despite improved skin condition with routine application of topical emollient ointments, the increased risk for CoNS and other nosocomial infections contradicts it use in preterm infants.
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