Primary Outcomes (end points)
The key outcomes are infant cognitive, psychomotor, and socio-emotional development. For children less than 30 months of age, cognitive and psychomotor outcomes are measured using the Bayley Scales of Infant Development, Version 1 (BSID-I). The BSID-I produced two sub-indices: the Mental Development Index (MDI), which evaluates memory, habitation, problem solving, early number concepts, generalization, classification, vocalization and language to produce a measure of cognitive development, and the Psychomotor Development Index (PDI), which evaluates gross motor skills (rolling, crawling and creeping, sitting and standing, walking, running and jumping) and fine motor skills to produce a measure of psychomotor development. For children older than 30 months of age these outcomes are assessed using the Griffith Mental Development Scales (GMDS-ER 2-8). The GMDS-ER 2-8 comprises six sub scales: locomotor, personal-social, language (receptive and expressive), hand and eye coordination, performance, practical reasoning.
An additional primary outcome is socio-emotional development as measured using the Ages and Stages Questionnaire: Social Emotional (ASQ:SE). The items in this questionnaire (which vary by age) measure a child's tendency towards a set of behaviors such as ability to calm down, accept directions, demonstrate feelings for others (empathy), communicate feelings, initiate social responses to parents and others, and respond without guidance (move to independence). Children scoring above a pre-determined threshold on the total score produced by the questionnaire are considered at risk of socio-emotional problems.