An Observational Cohort Study of Prognostic Value of Generalized Movements in the Diagnosis of Neurological Diseases in Children

According to hypothesis, assessment of general movements is an early diagnostic tool for neurological disorders in children.

Combined estimates of epidemiological studies of neurological diseases in children under 3-5 years of age show that from 5.7% to 9.2% of children may have neurological disorders in different areas of development. According to the statistical report, the birth rate in the Aktobe region for 2019 and 2020 varies from 18.7 to 21.3 per 1000, that is, the expected birth rate in the Regional Perinatal Center of 7000-7500 newborns in 2021. The number of children in the region is 77360. Adjusted for an alpha error of 5% and a beta threshold of 20% (80% power), to achieve a predictive power of 0.95 and in accordance with selection criteria, expected 155 children with neurological disorders. Taking into account the cumulative frequency of disorders of neurological development of 9.2% in the study group, the sample should include 1800 children.

The present observational study is conducted in a population cohort of children of the Aktobe region. The motor repertoire of children aged 0 to 5 months will be evaluate and its relationship with demographic, prenatal, perinatal factors and the outcome of neurological development in the second year of life. The study (evaluation of general movements) is carried out by 3 specialists: the first specialist (the main researcher is a doctoral student) has access to all the survey materials, evaluates general movements from video materials, has an initial level of knowledge on the evaluation of general movements; 2 the specialist has a basic level (project manager) - has access to video recordings, has limited access to evaluate other variables; 3 the specialist has an expert level of knowledge (supervisor on a voluntary basis) on the evaluation of general movements, has access only to video recordings. As part of the pilot approach, all three specialists will evaluate the video recording of the movements of 50 infants, in the future it is planned to determine the reliability among evaluators using the Cohen's Kappa coefficient. Reliability will be considering high, when a coefficient of 0.61- 0.80 is reached.

The researcher on the 3rd-5th day of the child's life (home, hospital) explains in detail to parents the project being implemented. After receiving the informed consent of the parents, the researcher records the child's movements on video in accordance with the requirements, while simultaneously teaching the child's mother.

At the first stage, all full-term newborns will be examined. The examination is carried out no earlier than 3 days (adaptation period) after birth. At this stage, the child's general condition and neurological status will be assessed. Clinical data include the status of breastfeeding and the health status of the baby from the moment of birth. The Apgar scale will be used to assess the general condition of the newborn. In the presence of perinatal asphyxia, indicators on the Sarnat scale for neonatal encephalopathy will be used. Neonatal encephalopathy, acute encephalopathy and/or hypoxic-ischemic encephalopathy will be evaluated according to clinical and laboratory criteria. The following data will be evaluated: the sex of the baby, the age of the baby in days, a family member with a disability, the gestational age of the child at birth, birth weight, head circumference, the nutritional status of the baby (breast, artificial, mixed). These variables, except for the latter, are continuous (quantitative) indicators, all other data will be categorical. The weight and circumference of the child's head will be considered a pathology if the deviation is more than 2 standard deviations (SD) below the median (according to WHO). All data is entered into a specially designed individual registration card.