Outcomes and their ascertainment
SECONDARY
The primary outcomes were cognitive, motor and language scores at 12 and 24 months of age. The secondary outcomes were socio-emotional scores at 12 and 24 months of age, infant temperament scores at 12 months of age, and mean internalising and externalising behaviour scores at 24 months of age. A window period of +4 weeks was considered for the assessments to be conducted. Details of the data collection have been presented previouslyFor the neurodevelopmental outcomes, an independent team of trained and standardised psychologists conducted the assessments. This team was blinded to the group allocation. For the primary outcomes, Bayley Scales of Infant and Toddler Development (BSID), 3rd edition was usedBehavioural problems were assessed using Child Behavior Checklist – preschool (CBCL). This is a caregiver-reported tool intended for children aged 18 months to 5 yearsWe also measured home environment and child stimulation by caregivers. Home environment at 12 months of child age was assessed using ‘Pediatric Review of Children’s Environmental Support and Stimulation (PROCESS)’ questionnaire