Neonatal Mortality Clinical Trial
Official title:
An Integrated Toolkit to Save Newborn Lives and Brains in Kenya
Each year, more than 3 million neonatal deaths occur worldwide and greater than 200 million children under the age of 5, almost all in low- and middle-income countries, are not fulfilling their developmental potential. The development of the growing brain can be affected through multiple mechanisms including the same insults that are major causes of mortality, namely hypothermia and infection. The first month of life is a crucial period in neurodevelopment (ND). In this study, the investigators propose the home-based use of an integrated evidence-based toolkit to improve health status, reduce the incidence of neonatal insults that may affect brain development, decrease neonatal mortality rate (NMR), and provide early identification of danger signs. The investigators hypothesize that use of the neonatal toolkit will result in an improvement of at least one standard deviation in neurodevelopment as measured at 12 months of age by the Protocol for Child Monitoring Infant and Toddler (PCM-IT) version.
Each year there are over 3 million global neonatal deaths. While significant progress has
been made on overall under 5 mortality over the past decade, minimal progress has been made
in reducing neonatal deaths and these now represent about 40% of all deaths in children
under the age of 5. The majority of neonatal deaths occur in rural areas of developing
countries and approximately two thirds are due to infection and complications relating to
low birth weight (LBW) and prematurity. Additionally, more than 200 million children under 5
years old, almost all in low- and middle-income countries (LMIC), are not fulfilling their
developmental potential. To date, most neonatal intervention trials in LMIC have focused on
reducing mortality and little research has been performed on the consequences of severe but
non-fatal neonatal insults on neurodevelopment (ND). Subsequently, little is known about
interventions that may reduce the risk of long-term neurocognitive sequelae.
The first month of life is a critical period in ND in which there is significant
neurogenesis, synaptogenesis, and myelination. Stimulation of the infant's brain during this
period may have significant downstream positive effects. Development of the growing brain
can be affected through multiple mechanisms including the same insults that are major causes
of mortality, namely hypothermia and infection. Reducing the incidence of these insults
during this period may not only save lives but also save brains and improve ND outcomes.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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