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NCT Number: NCT07596147

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.

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Key information

Conditions

High Risk Infant Disease Female Urogenital Diseases and Pregnancy Complications Mental Disorders Neurodevelopmental Disorder (Diagnosis) Neurodevelopmental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Health Sciences

Ankara, 06490, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bülent Elbasan

CONTACT

[email protected]

+9053 ext. +905324672923

Ecem Yıldız Çangur, PT, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Hand Assessment for Infants (HAI)

    Time frame: 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.

  2. Peabody Developmental Motor Scales - Second Edition (PDMS-2)

    Time frame: 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

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Acronym: SAFE-EFFECT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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