Clinical Research Directory

Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk

The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated in a neonatal intensive care unit (NICU) and are at mild-to-moderate developmental risk (for example, due to preterm birth or low birth weight). The study will also look at whether the program helps parents' stress and well-being. The main questions it aims to answer are: Does the remote family-centered early intervention program improve infants' motor, cognitive, language, and neurological development compared with standard care? Does the program reduce parental stress and anxiety and improve parents' perception of family-centered care? Researchers will compare an intervention group with a control group receiving standard information and routine follow-up, to see whether the program leads to better infant and parent outcomes. The study will include 36 infants (18 per group) with a corrected age of 6 to 10 months. Participants in the intervention group will: Attend weekly online sessions with the research team for 10 weeks Carry out a home-based developmental activity program with their infant Share short videos of home practice and receive feedback, with follow-up via messaging Participants in the control group will receive standard information and routine follow-up. Infant development will be assessed with the Bayley-III and SINDA, and parents will complete questionnaires on stress, anxiety, and family-centered care. Assessors will be blinded to group assignment.