Neonatal Infections Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Efficacy of the Use of a Neonatal Package to Reduce Neonatal Infection in a Rural District of Pakistan
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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