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Topically Applied Sunflower Seed Oil Prevents Invasive Bacterial Infections in Preterm Infants in Egypt: A Randomized, Controlled Clinical Trial

Darmstadt, Gary L. MD, MS†; Badrawi, Nadia MD‡; Law, Paul A. MD, MPH*; Ahmed, Saifuddin PhD*; Bashir, Moataza MD‡; Iskander, Iman MD‡; Said, Dalia Al MD‡; Kholy, Amani El MD‡; Husein, Mohamed Hassan MD‡; Alam, Asif MBBS§; Winch, Peter J. MD, MPH*; Gipson, Reginald MD||; Santosham, Muhammad MD, MPH*

Pediatric Infectious Disease Journal:
Original Studies
Abstract

Background: Because the therapeutic options for managing infections in neonates in developing countries are often limited, innovative approaches to preventing infections are needed. Topical therapy with skin barrier-enhancing products may be an effective strategy for improving neonatal outcomes, particularly among preterm, low birth weight infants whose skin barrier is temporarily but critically compromised as a result of immaturity.

Methods: We tested the impact of topical application of sunflower seed oil 3 times daily to preterm infants <34 weeks gestational age at the Kasr El-Aini neonatal intensive care unit at Cairo University on skin condition, rates of nosocomial infections and mortality.

Results: Treatment with sunflower seed oil (n = 51) resulted in a significant improvement in skin condition (P = 0.037) and a highly significant reduction in the incidence of nosocomial infections (adjusted incidence ratio, 0.46; 95% confidence interval, 0.26–0.81; P = 0.007) compared with infants not receiving topical prophylaxis (n = 52). There were no reported adverse events as a result of topical therapy.

Conclusions: Given the low cost (~$.20 for a course of therapy) and technologic simplicity of the intervention and the effect size observed in this study, a clinical trial with increased numbers of subjects is indicated to evaluate the potential of topical therapy to reduce infections and save newborn lives in developing countries.

Author Information

From the *Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; the †Office of Health, Save the Children Federation—USA, Washington, DC; the ‡Departments of Pediatrics, Clinical Pathology and Public Health, Faculty of Medicine, Cairo University, Cairo, Egypt; the §Institute of Child Health, Dhaka Shishu Hospital, Dhaka, Bangladesh; and the ||Healthy Mother Healthy Child Results Package, John Snow, Inc, Cairo, Egypt

Accepted for publication April 5, 2004.

Supported primarily by The United States Agency for International Development, through the Healthy Mother Healthy Child Results Package grant to John Snow, Inc., Cairo, Egypt. Support for development of study design and data management and analysis was also provided by the Thrasher Research Fund, the Society for Pediatric Dermatology, the Johns Hopkins Family Health and Child Survival Cooperative Agreement with the United States Agency for International Development and Save the Children Federation-USA through a grant from the Bill and Melinda Gates Foundation.

Presented in part at the meeting of the International Society of Bioengineering and the Skin, Baltimore, MD, October 25, 2002.

Address for reprints: Gary L. Darmstadt, MD, Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205. Fax 410-614-1419; E-mail gdarmsta@jhsph.edu.

© 2004 Lippincott Williams & Wilkins, Inc.