Neonatal Mortality Clinical Trial
Official title:
An Integrated Toolkit to Save Newborn Lives in Pakistan
There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are due to infection, low birth weight (LBW), and prematurity. Low tech but high impact interventions and commodities used in unconventional ways could save hundreds of thousands of newborn lives. We propose an integrated evidence-based toolkit usable by community health workers (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied to the umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to identify hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.
Over 3 million global neonatal deaths are reported annually. While significant progress has
been made over the past decade towards reducing overall under 5 mortality, very little
progress has been made towards the reduction of neonatal deaths, which represent about 40%
of all deaths in children under the age of 5. The majority of neonatal deaths occur in rural
areas of low-income countries and approximately two thirds are due to infection and
complications relating to low birth weight (LBW) and prematurity.
In Pakistan, it is estimated that over 200,000 newborns die each year before they reach the
end of their first month of life, representing nearly 58% of all deaths among children under
the age of five. The risk of neonatal death in Pakistan is higher in rural areas than in
urban areas; the neonatal mortality rate (NMR) in rural areas is 55 per 1,000 live births
compared to 48 per 1,000 live births in urban areas. NMR in Pakistan is also associated with
poverty; the NMR in highest wealth quintile is 38 compared to 63 per 1000 live births in
lowest wealth quintile.
In resource poor settings, newborns are most often delivered at home and receive minimal
specific medical care, measurement, or monitoring. In these areas, geography,
infrastructure, and poverty often effectively prevent access to health centers and care.
Home outreach with trained Community health workers (CHWs) is increasingly recognized as the
mainstay for provision of maternal and newborn care in these settings. Many proven,
cost-effective ways to save the lives of newborns exist, however, they are not always
available to those who need them most nor have they been packaged into a single portable kit
that can be easily used in the home-setting. Such a portable kit consisting of low cost,
evidence-based interventions for use in the home has tremendous potential to improve health
status and decrease NMR.
In this study, the investigators hypothesize that the implementation of an integrated
evidence-based toolkit by CHWs will reduce neonatal deaths by at least 40% through a
reduction in both infectious causes of death and those associated with prematurity and LBW.
Furthermore, the investigators propose that there will be an additive effect from the
mortality benefit of specific kit components. The portable kit will contain a clean birth
kit to be used at the time of delivery either at home or in a facility, 4% chlorhexidine
(CHX) lotion, sunflower oil emollient, ThermoSpot, a Mylar infant sleeve, and a reusable,
non-electric, heating device. CHWs will be equipped with a hand held electric scale to
identify LBW newborns.
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