Effect of provision of an integrated neonatal survival kit and early cognitive stimulation package by community health workers on developmental outcomes of infants in Kwale County, Kenya: study protocol for a cluster randomized trial.
Each year, more than 200 million children under the age of 5 years, almost all in low- and middle-income countries (LMICs), fail to achieve their developmental potential. Risk factors for compromised development often coexist and include inadequate cognitive stimulation, poverty, nutritional deficiencies, infection and complications of being born low birthweight and/or premature. Moreover, many of these risk factors are closely associated with newborn morbidity and mortality. As compromised development has significant implications on human capital, inexpensive and scalable interventions are urgently needed to promote neurodevelopment and reduce risk factors for impaired development.



This cluster randomized trial aims at evaluating the impact of volunteer community health workers delivering either an integrated neonatal survival kit, an early stimulation package, or a combination of both interventions, to pregnant women during their third trimester of pregnancy, compared to the current standard of care in Kwale County, Kenya. The neonatal survival kit comprises a clean delivery kit (sterile blade, cord clamp, clean plastic sheet, surgical gloves and hand soap), sunflower oil emollient, chlorhexidine, ThermoSpot(TM), Mylar infant sleeve, and a reusable instant heater. Community health workers are also equipped with a portable hand-held electric scale. The early cognitive stimulation package focuses on enhancing caregiver practices by teaching caregivers three key messages that comprise combining a gentle touch with making eye contact and talking to children, responsive feeding and caregiving, and singing. The primary outcome measure is child development at 12 months of age assessed with the Protocol for Child Monitoring (Infant and Toddler version). The main secondary outcome is newborn mortality.



This study will provide evidence on effectiveness of delivering an innovative neonatal survival kit and/or early stimulation package to pregnant women in Kwale County, Kenya. Study findings will help inform policy on the most appropriate interventions for promoting healthy brain development and reduction of newborn morbidity and mortality in Kenya and other similar settings.



ClinicalTrial.gov NCT02208960 (August 1, 2014).
Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada.
Lisa G
LG
Pell
Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada.
Diego G
DG
Bassani
Department of Community Health, Faculty of Health Sciences, Aga Khan University, Mombasa, Kenya.
Lucy
L
Nyaga
Department of Community Health, Faculty of Health Sciences, Aga Khan University, Mombasa, Kenya.
Isaac
I
Njagi
Department of Community Health, Faculty of Health Sciences, Aga Khan University, Mombasa, Kenya.
Catherine
C
Wanjiku
Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada.
Thulasi
T
Thiruchselvam
Department of Paediatrics and Child Health, Aga Khan University Hospital, Nairobi, Kenya.
William
W
Macharia
Department of Pediatrics, St Michael's Hospital, University of Toronto, Toronto, Canada.
Ripudaman S
RS
Minhas
Institute for Human Development, Aga Khan University, Nairobi, Kenya.
Patricia
P
Kitsao-Wekulo
Department of Community Health, Faculty of Health Sciences, Aga Khan University, Mombasa, Kenya.
Amyn
A
Lakhani
Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada.|Center of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.
Zulfiqar A
ZA
Bhutta
Medical College, Faculty of Health Sciences, Aga Khan University, Nairobi, Kenya.
Robert
R
Armstrong
Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada. shaun.morris@sickkids.ca.|Department of Paediatrics, Faculty of Medicine, University of Toronto, Toronto, Canada. shaun.morris@sickkids.ca.|Division of Infectious Diseases, The Hospital for Sick Children, Toronto, Canada. shaun.morris@sickkids.ca.
Shaun K
SK
Morris
D017028:Caregivers / Q000193:education*; D002657:Child Development; D002985:Clinical Protocols; D003071:Cognition; D003153:Community Health Services / Q000379:methods*; D003150:Community Health Workers; D054626:Consumer Health Information / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D007224:Infant Care / Q000379:methods; D007231:Infant, Newborn; D007630:Kenya; D008297:Male; D011247:Pregnancy; D011263:Pregnancy Trimester, Third; D015397:Program Evaluation; D014838:Volunteers
Child development; Community health workers; Kenya; Neonatal mortality; Stimulation