Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial

Pediatrics. 2008 Mar;121(3):522-9. doi: 10.1542/peds.2007-0213.


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: < or = 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Administration, Topical
  • Cross Infection / mortality
  • Cross Infection / prevention & control*
  • Developing Countries
  • Emollients / therapeutic use*
  • Female
  • Humans
  • Incidence
  • India
  • Infant Mortality / trends*
  • Infant, Newborn
  • Infant, Premature*
  • Infant, Premature, Diseases / mortality*
  • Infant, Premature, Diseases / prevention & control*
  • Infant, Very Low Birth Weight
  • Intensive Care Units, Neonatal
  • Male
  • Petrolatum / administration & dosage
  • Plant Oils / administration & dosage
  • Probability
  • Prospective Studies
  • Reference Values
  • Skin Absorption
  • Sunflower Oil
  • Survival Analysis
  • Treatment Outcome


  • Emollients
  • Plant Oils
  • Sunflower Oil
  • Petrolatum