Newborn Kit to Save Lives and Brains in Kenya

PHASE3CompletedINTERVENTIONAL
Enrollment

2,294

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
NeurodevelopmentNeonatal 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"

Trial Locations (1)

Unknown

Aga Khan University, Nairobi

All Listed Sponsors
collaborator

Grand Challenges Canada

OTHER

collaborator

March of Dimes

OTHER

collaborator

Aga Khan University

OTHER

lead

The Hospital for Sick Children

OTHER

NCT02208960 - Newborn Kit to Save Lives and Brains in Kenya | Biotech Hunter | Biotech Hunter