SAFE Early Intervention for At-Risk Infants

NCT07596147 — Not applicable, Recruiting, 34 participants, Gazi University

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Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants

Registry	NCT07596147, acronym SAFE-EFFECT
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	34 (Estimated)
Sponsor	Gazi University (Other)
Conditions	High Risk Infant, Neurodevelopmental Disorder (Diagnosis), Preterm
Interventions	SAFE Early Intervention Program, NDT TREATMENT (Behavioral)
Dates	start 2026-02-16, primary completion 2026-06-16 (estimated), completion 2026-07-16 (estimated), first posted 2026-05-19, last updated 2026-05-19
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Detailed description

This randomized controlled study investigates the effects of two different early intervention approaches in high-risk infants. The SAFE intervention program is compared with conventional Neurodevelopmental Treatment (NDT). Assessments include upper extremity function, fine motor development, and developmental outcomes measured at baseline and follow-up periods. The study aims to determine which intervention provides superior improvement in early motor and developmental skills.

+Arms and interventions

Arm	Type	Interventions	Description
SAFE EARLY İNTERVENTION group	Experimental	Behavioral: SAFE Early Intervention Program	SAFE-based early intervention for high-risk infants: The SAFE early intervention approach will be implemented to improve proximal stabilisation in high-risk infants aged between 3 and 12 months.
NDT TREATMENT GROUP	Active comparator	Behavioral: NDT TREATMENT	Neurodevelopmental Treatment (NDT): The NDT approach, which aims to develop fine motor skills in high-risk infants aged between 3 and 12 months, will be implemented

SAFE Early Intervention Program (Behavioral): Structured 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 (Behavioral): Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week

+Outcome measures

Primary outcomes

Hand Assessment for Infants (HAI) [Baseline and after 8 weeks of intervention]: 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.
Peabody Developmental Motor Scales - Second Edition (PDMS-2) [Baseline and after 8 weeks of intervention]: 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.

Secondary outcomes

Canadian Occupational Performance Measure (COPM) [Baseline and after 8 weeks of intervention]: 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.
PedsQL™ Infant Quality of Life Scale (1-12 Months) [Baseline and after 8 weeks of intervention]: 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.

+Eligibility

Sex: All, ages: 3 Months to 12 Months

Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki

+Locations (1)

Facility	City	Country	Status
Gazi University Faculty of Health Sciences	Ankara, Ankara	Turkey (Türkiye)	Recruiting