Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
Condition: Neonatal Sepsis; Low Birth Weight
MeSH terms: Neonatal Sepsis; Body Weight; Birth Weight
Study type: Interventional

Summary: 
      The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine
      affects skin condition, temperature, and bacterial colonization in stable preterm (28-36
      weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.
    

Detailed description: 
      Infections are the leading cause of death in neonates admitted to hospital - studies from
      developing countries suggest that about 25-71% of deaths occurring in neonatal intensive care
      units are secondary to infections.Such high infection-related mortality mandates an urgent
      implementation of simple and effective measures to prevent the occurrence of infections in
      these units.

      The majority of neonatal infections occur in the first two weeks of life, when the epidermal
      barrier is immature and functionally compromised. Topical application of antiseptics until
      the skin matures could theoretically prevent skin colonization and reduce the incidence of
      systemic infections in neonates. Chlorhexidine, a broad-spectrum antiseptic used frequently
      for umbilical cord care in neonates, is now being evaluated for topical application to the
      skin. Hospital-based studies, involving predominantly term infants, have shown reductions in
      skin flora8 and a reduction in the incidence of sepsis following topical chlorhexidine
      application. In a community-based study in Nepal, a single skin cleansing with 0.25%
      chlorhexidine resulted in reduction in mortality among low birth weight infants; though the
      mechanism of the impact could not be determined, it was presumably due to increased
      susceptibility to transcutaneous sepsis in the low birth weight group.

      Since the risk of infection in neonates is inversely related to their gestation, it is
      essential to evaluate the effect and the mechanism of such intervention in preterm neonates.
      These infants are, however, more prone to develop skin reactions following use of topical
      antiseptics. Preterm infants are also more prone to develop hypothermia following
      bathing/cleansing with antiseptic solution(s).

      Since few studies have evaluated the effects of topical application of chlorhexidine in
      preterm infants admitted in a health care facility, we conducted the present study to examine
      if single skin cleansing with 0.25% chlorhexidine immediately after birth affects skin
      condition, temperature, and colonization in hospitalized preterm low birth weight infants.
    

Intervention name(s): Chlorhexidine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate); Cleansing the skin (except the face)with baby wipes containing normal saline
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: chlorhexidine; preterm; newborn; skin condition; temperature; skin flora