Neurodevelopment
Conditions
Interventions
Study setting
Colombo North Teaching Hospital (CNTH) and multidisciplinary clinic at Department of Disability Studies, Ragama.
Randomization
The children will be randomized to 3 groups (3 arms - 2 i
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: • Babies born at Colombo North Teaching Hospital • Having one or more risk factors for adverse neurodevelopmental outcome: Prematurity (<37/52), placental abnormalities (maternal DM, HT), low birthweight (<2500g), birth asphyxia/ hypoxic ischaemic encephalopathy, neonatal jaundice, neonatal seizures, respiratory distress syndrome, hypoglycaemia and neonatal infection. • Having abnormal writhing general movement assessment as concluded by two of the three assessors.cramped synchronized, poor repertoire or chaotic movements, in the two video assessments at two consecutive time points two weeks apart. • infants must live in the study geographical areas to facilitate follow up • Families agreeing to take part for the full study period of 6 months (with the provision to withdraw as per the informed consent sheet)
Exclusion criteria
Exclusion criteria: • Infants who have major structural abnormality in other body system. Eg: Cardiac anomaly, which may interfere with motor functions • Genetic syndrome or metabolic syndrome which usually has impact on neurodevelopmental outcome • Subjects who have difficulty complying with the intervention (unavailability of a smart phone which is compatible with videoconferencing) • Inconclusive general movement assessment • Subjects who do not consent for the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean scores of the GMFM-66. The Gross Motor Function Measure (GMFM-66) is a standardised criterion referenced measurement tools designed to measure gross motor function over time for children with disabilities. [Baseline (T0), Post intervention 3 months (T1), Post intervention 6 months (T2)] | — |
Secondary
| Measure | Time frame |
|---|---|
| • Mean scores of the Canadian Occupational Performance measure(COPM) performance and satisfactory score. This measures the parent perceived change in their infants’ performance of prioritized goals and level of their satisfaction with progress. [Baseline (T0), Post intervention 3 months (T1), Post intervention 6 months (T2)] • Cost analysis using WHO CostIt software CostIt will be used to calculate the economic costs of interventions. [ Post intervention 6 months (T2)] | — |
Countries
Sri Lanka
Contacts
Public ContactDilini Vidyathilaka Vipulaguna
Senior Registrar, Community Paediatrics
Outcome results
None listed