Topical Emollient Therapy
Condition: Blood Stream Infection
MeSH terms: Sepsis
Study type: Interventional

Summary: 
      Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of
      these deaths are attributable to prematurity and infection. With the increasing rate of
      premature births in some settings, the mortality rate of over 50% among preterm babies in
      some of the developing countries require inexpensive hospital-based strategies to prevent
      fatal infections in newborns of these countries. As most of the deaths in preterm neonates
      are attributable to their vulnerability of infection, a potential low cost intervention like
      topical emollient therapy can be effectively directed to reduce infection related mortality
      and morbidity in the developing countries. Topical emollient therapy reduces the rate of
      infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss
      consequently conserving heat and energy to promote growth.

      The broad goal of the study is to improve the survival rate of hospitalized preterm neonates
      in the developing countries by decreasing the incidence of infection using low-cost
      interventions.

      HYPOTHESIS:

      It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day
      of life in hospitalized preterm neonates reduces the incidence proportion of hospital
      acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it
      is hypothesized that the weight gain in the neonates receiving prophylactic application of
      emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18
      more as compared to the weight gain in the routine skin care group.
    

Detailed description: 
      Research question:

        1. The primary research question to be addressed via this study is whether the prophylactic
           application of emollient, which is coconut oil twice a day till 28th day of life,
           effective in reducing the incidence proportion of hospital acquired infection among
           preterm neonates by 40% as compared to the routine skin care.

        2. The secondary research question is whether the weight gain in the neonates receiving
           prophylactic application of emollient, which is coconut oil twice a day till 28th day of
           life, is at least 2g/kg/day more as compared to the weight gain in the routine skin care
           group.

      Objectives: This study has the following primary objectives:

        1. To evaluate the effectiveness of topical emollient in preventing hospital acquired
           infection in preterm neonates.

           The secondary objective is:

        2. To compare the weight gain among the two groups of neonates.
    

Intervention name(s): Topical Emollient
Intervention type(s): Other
Intervention description(s): Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life
Intervention MeSH terms: Emollients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Topical Emollient Therapy; Emollient; Preterm; Hospital Acquired Infection