OBJECTIVE:Premature infants have an ineffective epidermal barrier. The aim of this study was to investigate the cutaneous and systemic effects of preservative-free topical ointment therapy in premature infants. STUDY DESIGN: We conducted a prospective, randomized study of 60 infants less than 33 weeks' estimated gestational age. The treated infants received therapy for 2 weeks with twice-daily preservative-free topical ointment therapy while the control group received no topical treatment or as-needed therapy with a water-in-oil emollient. Data collection included transepidermal water loss (TEWL) measurement, skin condition evaluations, fungal and quantitative bacterial skin cultures, analysis of fluid requirements, patterns of weight low or gain, and the incidence of blood and cerebrospinal fluid cultures positive for microorganisms. RESULTS: We found that topical ointment therapy significantly decreased TEWL during the first 6 hours after the initial application. TEWL was decreased by 67% (p = 0.0001) when measured 30 minutes after application and 34% (p = 0.001) when measured 4 to 6 hours after application. We also observed significantly superior skin condition scores in the treated group on study days 7 and 14 (p = 0.001) and 0.0004, respectively). Quantitative bacterial cultures revealed significantly less colonization of the axilla on day 2, 3, or 4 and on day 14 (p = 0.008 and 0.04, respectively). The incidence of positive findings in blood and/or cerebrospinal fluid cultures was 3.3% in the treated group of infants versus 26.7% in the control group (p = 0.02). There was no statistical difference in the fluid requirements or patterns of weight gain or loss during the 2 weeks of the study. CONCLUSIONS:Preservative-free topical ointment therapy decreased TEWL for 6 hours after application, decreased the severity of dermatitis, and decreased bacterial colonization of axillary skin. Infants treated with ointment had fewer blood and cerebrospinal fluid cultures positive for microorganisms. These data support the use of topical ointment therapy in very premature infants during the first weeks after birth.
RCT Entities:
OBJECTIVE: Premature infants have an ineffective epidermal barrier. The aim of this study was to investigate the cutaneous and systemic effects of preservative-free topical ointment therapy in premature infants. STUDY DESIGN: We conducted a prospective, randomized study of 60 infants less than 33 weeks' estimated gestational age. The treated infants received therapy for 2 weeks with twice-daily preservative-free topical ointment therapy while the control group received no topical treatment or as-needed therapy with a water-in-oil emollient. Data collection included transepidermal water loss (TEWL) measurement, skin condition evaluations, fungal and quantitative bacterial skin cultures, analysis of fluid requirements, patterns of weight low or gain, and the incidence of blood and cerebrospinal fluid cultures positive for microorganisms. RESULTS: We found that topical ointment therapy significantly decreased TEWL during the first 6 hours after the initial application. TEWL was decreased by 67% (p = 0.0001) when measured 30 minutes after application and 34% (p = 0.001) when measured 4 to 6 hours after application. We also observed significantly superior skin condition scores in the treated group on study days 7 and 14 (p = 0.001) and 0.0004, respectively). Quantitative bacterial cultures revealed significantly less colonization of the axilla on day 2, 3, or 4 and on day 14 (p = 0.008 and 0.04, respectively). The incidence of positive findings in blood and/or cerebrospinal fluid cultures was 3.3% in the treated group of infants versus 26.7% in the control group (p = 0.02). There was no statistical difference in the fluid requirements or patterns of weight gain or loss during the 2 weeks of the study. CONCLUSIONS: Preservative-free topical ointment therapy decreased TEWL for 6 hours after application, decreased the severity of dermatitis, and decreased bacterial colonization of axillary skin. Infants treated with ointment had fewer blood and cerebrospinal fluid cultures positive for microorganisms. These data support the use of topical ointment therapy in very premature infants during the first weeks after birth.
Authors: Maeve M Kelleher; Suzie Cro; Victoria Cornelius; Karin C Lodrup Carlsen; Håvard O Skjerven; Eva M Rehbinder; Adrian J Lowe; Eishika Dissanayake; Naoki Shimojo; Kaori Yonezawa; Yukihiro Ohya; Kiwako Yamamoto-Hanada; Kumiko Morita; Emma Axon; Christian Surber; Michael Cork; Alison Cooke; Lien Tran; Eleanor Van Vogt; Jochen Schmitt; Stephan Weidinger; Danielle McClanahan; Eric Simpson; Lelia Duley; Lisa M Askie; Joanne R Chalmers; Hywel C Williams; Robert J Boyle Journal: Cochrane Database Syst Rev Date: 2021-02-05