The gross motor domain of the INTER-NDA was complemented by the evaluation of the age of achievement of the matching WHO gross motor development milestones “standing alone” and “walking alone”16 (link). Information was obtained at both the 1- and 2-year follow-up visits in order to evaluate consistency. In cases of disagreement (19 cases out of 1292 for “standing alone” and 18 cases out of 1296 for “walking alone”), the 1-year information was selected as the preferred data point.
Vision was assessed using the Cardiff Visual Acuity and Contrast Sensitivity tests17 (link) for binocular vision. These tests are indicators of the integrity of the visual pathway and central nervous system and were considered robust “biological controls”, complementing the fine and gross motor items. Importantly, both tests are directly observed neurodevelopmental markers, unlikely to be affected by cultural influences.
The administration of the INTERGROWTH-21st Neurodevelopment Package was supported by an electronic and tablet-based data collection and management system developed for this study, which contains the INTER-NDA operation manual, visual cues, examples, and fully integrated quality checks13 (link). Staff administering the assessments were aware of the general principles of the Project but not the specific hypothesis being tested. In addition, they were unaware of the INTER-NDA domain and total scores for individual children, as well as for their own and all the other study sites. Data were uploaded to centralised data-servers as soon as each assessment ended. The data management team performed monthly checks on the site-based and centralised databases (