Published online February 29, 2008
PEDIATRICS Vol. 121 No. 3 March 2008, pp. 522-529 (doi:10.1542/peds.2007-0213)
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ARTICLE

Effect of Skin Barrier Therapy on Neonatal Mortality Rates in Preterm Infants in Bangladesh: A Randomized, Controlled, Clinical Trial

Gary L. Darmstadt, MD, MSa, Samir K. Saha, PhDb, A.S.M. Nawshad Uddin Ahmed, MBBS, FRCPc, Saifuddin Ahmed, PhDd, M.A.K. Azad Chowdhury, MBBS, FRCPe, Paul A. Law, MD, MPHf, Rebecca E. Rosenberg, MD, MPHa, Robert E. Black, MD, MPHa and Mathuram Santosham, MD, MPHa

a Departments of International Health
d Population and Family Health Sciences, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
b Departments of Microbiology
e Neonatology, Bangladesh Institute of Child Health, Dhaka Shishu Hospital, Dhaka, Bangladesh
c Department of Pediatrics, Kumudini Women's Medical College, Mirzapur, Tangail, Bangladesh
f Department of Medical Informatics, Kennedy Krieger Institute, Johns Hopkins Medical Institutions, Baltimore, Maryland

OBJECTIVE. Skin barrier therapy during the neonatal period, when the skin barrier is most highly compromised and the risk of death is greatest, has been shown to have a number of potential benefits, including reduced risk of nosocomial sepsis. Topical application of emollients that augment skin barrier function was evaluated as a strategy for improving survival rates among hospitalized preterm infants in Bangladesh.

METHODS. A prospective, randomized, controlled, clinical trial was conducted in the special care nursery at Dhaka Shishu (Children) Hospital, the largest tertiary care children's hospital in Bangladesh. Preterm infants (gestational age: ≤33 weeks; N = 497) received daily topical applications of sunflower seed oil or Aquaphor ointment. Neonatal mortality rates were compared in an intent-to-treat analysis with a control group that did not receive emollient therapy.

RESULTS. Treatment with sunflower seed oil resulted in a statistically significant 26% reduction in mortality rates, compared with infants not receiving topical emollient therapy. Aquaphor therapy also significantly reduced mortality rates, by 32%.

CONCLUSIONS. Topical therapy with skin barrier-enhancing emollients improved survival rates among preterm hospitalized infants in Bangladesh. This study provides strong evidence for the implementation of topical therapy for high-risk preterm neonates in developing countries.

Key Words: developing country • emollient • low birth weight • mortality • preterm

Abbreviations: SSO—sunflower seed oil • CI—confidence interval

Accepted Aug 20, 2007.