Neonatal Package Study in Rural District of Pakistan
Condition: Neonatal Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of
      the issue and well recognized interventions the investigators are proposing a randomized
      controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a
      neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and
      application of chlorhexidine compared with standard neonatal care coupled with application of
      chlorhexidine and essential neonatal care alone. The investigators anticipate that this study
      will provide an evidence base way forward benefiting the children of Pakistan.
    

Detailed description: 
      The global neonatal mortality burden is one of the imminent factors which derail the
      achievement of the MDG 4 in many developing countries including Pakistan. Four million
      infants infants die in their first 28 days of their lives which account for about 40% of the
      total under-five mortality. The burden of neonatal mortality in Pakistan is alarming as the
      current neonatal mortality rate (NMR) is 55 per 1000 live births, third worst in the world.
      The major causes of these deaths are infections, preterm births and birth asphyxia which are
      avoidable. Despite many initiatives the NMR remains unchanged since last decade in Pakistan.

      Literature shows that low cost facility and community based interventions can reduce NMR
      significantly. Early neonatal care, application of chlorhexidine for cord care and Kangaroo
      Mother Care (KMC) have been recognized as effective intervention in reduction of neonatal
      morbidity and subsequently neonatal mortality in many developing countries. However these
      interventions have never been tested as a package and data about their combined effect is
      scarce both in Pakistan and developing countries.

      Considering the importance of the issue and well recognized interventions we are proposing a
      randomized controlled trial in a rural district of Pakistan which will evaluate the
      effectiveness of a neonatal package comprised of the standard neonatal care, KMC and
      application of chlorhexidine compared with standard neonatal care coupled with application of
      chlorhexidine and standard neonatal care alone. We anticipate that this study will provide an
      evidence base way forward benefiting the children of Pakistan.
    

Intervention name(s): Chlorhexidine; Kangaroo Mother Care; Essential Neonatal Care
Intervention type(s): Drug; Other; Other
Intervention description(s): 4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10; Skin to Skin Care which is Kangaroo mother care will be carried out by mother from Day 1 till the study completion; Essential Neonatal Care ensures delayed bathing, use of colostrum, exclusive breast feeding, skin to skin care for hypothermia, dry cord care, eye care and immunization for the newborn
Other intervention name(s): Antiseptic
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chlorhexidine; Kangaroo mother care; RCT