SAFE Early Intervention for At-Risk Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorGazi University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent
Disqualifiers
Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki
Trial design
Design model
Parallel
Treatments tested in this trial
SAFE Early Intervention Program
BehavioralStructured early intervention program designed for high-risk infants focusing on upper extremity function, fine motor development, and neurodevelopmental outcomes during 8 weeks, 5 days/week
NDT TREATMENT
BehavioralConventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: SAFE EARLY İNTERVENTION groupExperimental treatment 1 intervention
Group B: NDT TREATMENT GROUPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hand Assessment for Infants (HAI)
he Hand Assessment for Infants (HAI) will be used to evaluate upper extremity and hand function in high-risk infants through observational video analysis. The assessment includes reaching, grasping, object manipulation, bilateral hand use, and spontaneous hand movements during structured play activities.
Time frame
Baseline and after 8 weeks of intervention2
Peabody Developmental Motor Scales - Second Edition (PDMS-2)
The Peabody Developmental Motor Scales - Second Edition (PDMS-2) will be used to assess gross and fine motor development in high-risk infants aged 3-12 months. The assessment includes reflexes, stationary skills, locomotion, object manipulation, grasping, and visual-motor integration. Higher scores indicate better motor performance and developmental function.
Time frame
Baseline and after 8 weeks of interventionSecondary outcomes
1
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) will be used to evaluate parent-perceived performance and satisfaction related to the infant's functional goals. Parents will identify important activity-related goals and rate performance and satisfaction using a 10-point scale. Higher scores indicate better occupational performance and greater parental satisfaction.
Time frame
Baseline and after 8 weeks of intervention2
PedsQL™ Infant Quality of Life Scale (1-12 Months)
The PedsQL™ Infant Quality of Life Scale will be used to assess health-related quality of life in infants based on parent report. The scale evaluates physical functioning, emotional status, social interaction, and general well-being. Higher scores indicate better quality of life.
Time frame
Baseline and after 8 weeks of interventionSponsors and contacts
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Source ClinicalTrials.gov