Newborn Kit to Save Lives and Brains in Kenya

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.

Conditions

• Neurodevelopment
• Neonatal Mortality

Interventions

DEVICE

Neonatal Kit

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.

BEHAVIORAL

Neonatal Stimulation

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

Sponsors & Collaborators

• Grand Challenges Canada

  collaborator OTHER

• March of Dimes

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Shaun K Morris, MD, MPH · The Hospital for Sick Children

• Robert Armstrong · Aga Khan University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Kenya

Study Locations