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.

SAFE Early Intervention for At-Risk Infants

This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group. Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities. Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills. Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.