Clinical trial NCT02208960: Newborn Kit to Save Lives and Brains in Kenya
Official title: An Integrated Toolkit to Save Newborn Lives and Brains in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neurodevelopment
Neonatal Mortality
Keywords: Neurodevelopment
Neonatal kit
Kenya
Cluster Randomized Controlled Trial
Chlorhexidine
ThermoSpot
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: March of Dimes
name: Aga Khan University
First posted: 2014-08-05
Enrollment: 2294
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

i. All pregnant women in parts of study clusters covered by CHW program and their home- or facility-born live newborns.

ii. Mothers intending to maintain residence in study area for first 12 months of newborn's life.

Exclusion Criteria:

i. Failure to provide consent to enroll in study (intervention or control clusters).

Primary outcomes:
measure: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment
timeFrame: 12 months of age
Secondary outcomes:
measure: Neonatal mortality
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
measure: Incidence of omphalitis
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
measure: Incidence of severe infection
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
measure: Cases of hypothermia identified
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
measure: Cases of hyperthermia identified
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
measure: Number of LBW babies identified
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
measure: Health facility use
timeFrame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Aga Khan University
Study officials:
affiliation: The Hospital for Sick Children
name: Shaun K Morris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Robert Armstrong
role: PRINCIPAL_INVESTIGATOR
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