SAFE early intervention for high-risk infants to support arm function
Official 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
Run by Gazi University · NCT07596147 · Data updated 2026-11-12
This randomized trial tests whether the SAFE early intervention helps improve upper limb function and early development in high-risk infants aged 3–12 months compared with standard Neurodevelopmental Treatment (NDT).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Months to 12 Months |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Gazi University Academic / other |
| Locations | 1 site (Ankara, Ankara) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | June 16, 2026 |
| Study ends | July 16, 2026 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07596147 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants aged 3 to 12 months corrected age at enrollment with neurodevelopmental risk factors (e.g., prematurity, perinatal brain injuries) and admission to the Gazi University Developmental Pediatrics unit.
✕Probably not a fit
Infants without measurable upper limb or developmental delay or those too ill to participate may not benefit; some may not respond to early intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized study, 30 high-risk infants admitted to the Gazi University Developmental Physiotherapy and Pediatric Rehabilitation Unit are assigned to either the SAFE early intervention or Neurodevelopmental Treatment (NDT) for 8 weeks. The SAFE program emphasizes environmental enrichment, voluntary movements, sensory input, fine motor skill practice, postural control, and parent–infant engagement during daily activities. Outcomes include upper extremity function, fine motor development, and broader developmental measures assessed at baseline and after the intervention. The trial aims to determine which approach yields greater improvements in early motor and developmental skills in this vulnerable population.
Why it matters
Potential benefit: If successful, the SAFE program could offer improved early motor function and developmental trajectories for high-risk infants.
How similar studies have gone: Earlier studies of early motor interventions in similar populations have shown potential benefits for motor outcomes, though direct SAFE vs. NDT comparisons are novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Gazi University Faculty of Health Sciences
Ankara, Ankara, Turkey (Türkiye) Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.