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Trials - SLCTR/2019/014

Protocol Change

Date

2020-08-06


Protocol

Protocol changed


Item Changed

Primary outcome(s)


Previous Version

01.Child anthropometric measurements – height/length and weight at baseline and endline (after 6 months) to derive anthropometric indices (weight-for-age, weight-height and height-for-age) using instruments (Seca brand), with the support of trained data collectors; WHO Anthro software will be used to compute standard z-scores of weight for age, height for age and weight for height versus WHO 2007 reference population 02.Child age-appropriate development of language, cognitive, social-emotional and motor development Caregiver reported early childhood development Instrument (CREDI) to measure child age-appropriate development for language, cognitive, social-emotional and motor development. Bayley-III, screening of child development in four domains (language, cognitive, social-emotional and motor), will be applied to a nested sample of children from control and intervention sites, by trained psychometricians or paediatricians. [Base line and after 6 months ]


Next Version

The end measurements will be carried out via telephone interviews due to restrictions as a result of COVID19. The following end line measures will be carried out: The caregiver reported early childhood development Instrument (CREDI) to measure child age-appropriate development for language, cognitive, social-emotional and motor development. The following end line measures will NOT be carried out due to the prevailing situation in the country: 01.Bayley-III, screening of child development in four domains (language, cognitive, social-emotional and motor) applied to a nested sample of children from control and intervention sites, by trained psychometricians or paediatricians. 02.Child anthropometric measurements – height/length and weight at endline (after 6 months) to derive anthropometric indices (weight-for-age, weight-height and height-for-age) using instruments (Seca brand), with the support of trained data collectors;