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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,294
Contents of the neonatal kit: 1. Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp. 2. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls. 3. Sunflower oil emollient (50 mL) 4. ThermoSpot 5. Mylar infant sleeve 6. Click to heat warmer (http://www.heatinaclick.ca/products/pocket\_size.html) in a fitted cloth pouch. 7. Handheld battery-operated scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Community Health Worker.
A sub-set of children in the study will receive a neonatal stimulation program either on its own or in combination with the neonatal kit described above. The stimulation program will focus on teaching three key messages to enhance the caregivers' current caregiving practices, and each message is to be integrated into daily activities (e.g. during feeding, bathing, bedtime routines). By integrating the delivery of the interventions into the caregivers' daily routine, no additional time inconvenience will be added to their schedules. The key messages include: 1. Eye contact and talking to children 2. Responsive feeding and caregiving 3. Singing songs, including those with gentle touch
Aga Khan University
Nairobi, Kenya
Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment
The Protocol for Child Monitoring - Infant and Toddler (PCM-IT) version was designed in Kenya to assess neurodevelopment in resource-limited settings.
Time frame: 12 months of age
Neonatal mortality
Death from any cause within the first 28 days of life
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Incidence of omphalitis
Incidence of omphalitis where omphalitis is defined as: 1. None (no redness or swelling) 2. Mild (inflammation limited to the cord stump) 3. Moderate (inflammation extending less than 2cm to the skin at the base of the cord stump) 4. Severe (inflammation extending more than 2cm from the cord stump)
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Incidence of severe infection
Defined as: Convulsions OR fast breathing (60 breaths per minute or more) OR severe chest indrawing OR movement only when stimulated or no movement at all OR not feeding at all for at least 12 hours.
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Cases of hypothermia identified
Defined using ThermoSpot as: 1. Moderate hypothermia: pale green and red face (35ºC to 36ºC) 2. Severe hypothermia: black face (\<35ºC)
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Cases of hyperthermia identified
Defined using ThermoSpot as: Hyperthermia: blue face (\>39ºC)
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Number of LBW babies identified
LBW defined as: \<2500 grams at first weighing
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Health facility use
Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
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