SAFE Early Intervention for At-Risk Infants

NCT07596147 | Recruiting

• 2 other identifiers: 2026 - 86THESIS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Risk Infant; Neurodevelopmental Disorder (Diagnosis); Preterm

Keywords

early intervention; high risk infant; upper limb function

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and after 8 weeks of intervention

• 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.

  Baseline and after 8 weeks of intervention

Secondary Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

  Baseline and after 8 weeks of intervention

• PedsQL™ Infant Quality of Life Scale (1-12 Months)

  Baseline and after 8 weeks of intervention

Study Arms (2)

SAFE EARLY İNTERVENTION group

EXPERIMENTAL

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.

Behavioral: SAFE Early Intervention Program

NDT TREATMENT GROUP

ACTIVE COMPARATOR

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

Behavioral: NDT TREATMENT

Interventions

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

SAFE EARLY İNTERVENTION group

NDT TREATMENT BEHAVIORAL

Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week

NDT TREATMENT GROUP

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences

Ankara, Ankara, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders; Disease; Premature Birth

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)