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SAFE Early Intervention for At-Risk Infants

Study acronym: SAFE-EFFECT
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 19, 2026 (before its estimated June 16, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
171 trials monitored
See 4 trials at risk
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.
Trial Details
NCT Number NCT07596147
Lead Sponsor Gazi University
Conditions
(from sponsor)
High Risk Infant, Neurodevelopmental Disorder (Diagnosis), Preterm
Related terms Disease, Neurodevelopmental Disorders, Premature Birth
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov