Effects of SAFE Early Intervention Approach in the First Months of Life in Infants at Risk: A Randomized Controlled Study.
Ayse Yildiz, Ramazan Yildiz, Umut Apaydin and 4 others
PMID 40435392WHAT IT FOUND
SAFE, a home-based physiotherapy programme built around sensory strategies and hands-off motor learning, outperformed NDT on motor scores and sensory processing in 26 at-risk infants over 12 weeks.
Cognitive and language scores improved in both groups with no between-group difference.
Key findings
01The Bayley-III motor composite score, the primary outcome, showed a significant time-by-group interaction in favour of SAFE (p = 0.003, ηp² = 0.31). SAFE improved by 28.71 points (from 85.42 to 114.14) while NDT improved by 12.83 points (from 86.25 to 99.08).
02ITSP-2 sensory processing scores for general, auditory, tactile, and total processing showed significant time-by-group interactions in favour of SAFE (all p < 0.05). Visual, vestibular, and oral processing scores did not differ between groups.
03Both groups improved on Bayley-III cognitive and language scores within their own groups, but no significant time-by-group interaction was found for either (cognitive T2 between-group p = 0.07; language interaction p > 0.05).
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
Only 26 infants completed the study out of 32 eligible, and the sample was drawn from a single rehabilitation unit in Turkey. The evaluators and treating therapists knew which group each infant was in, so outcome scoring was not blinded. Follow-up lasted only 12 weeks; the authors note that cognitive effects may not be visible at this time point and that long-term follow-up is needed. Inclusion criteria covered a broad range of risk factors (preterm, HIE, infection, growth restriction) rather than a specific diagnosis, making it hard to tell which subgroups benefited most. The sensory processing outcomes come from the ITSP-2, a parent-completed questionnaire, rather than an objective behavioural measure. The SAFE programme was developed and delivered by the same department that designed the study, and the authors declare no external funding or conflicts.
Declared interests
The authors declare no conflicts of interest. No funding source is named in the text.
The easy way to misread this
Do not read this as evidence that SAFE outperforms NDT across all developmental domains. The cognitive and language scores improved in both groups with no significant between-group difference, and the sensory findings rest on a parent-completed questionnaire rather than an objective measure. With 26 infants assessed by therapists who knew the group assignment, the motor advantage could reflect expectation or regression to the mean rather than a true treatment effect.
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