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Randomized Controlled Trial
. 2025 Oct;61(10):1662-1670.
doi: 10.1111/jpc.70191. Epub 2025 Sep 2.

Long-Term Neurodevelopmental Outcomes of the SAFE Early Intervention in Infants at Risk: A Randomised Controlled Trial

Ramazan Yildiz  1 , Ayse Yildiz  1 , Umut Apaydin  2 , Pelin Atalan Efkere  3 , Kivilcim Gucuyener  4 , Ibrahim Murat Hirfanoglu  5 , Bulent Elbasan  3
Affiliations
Randomized Controlled Trial

Long-Term Neurodevelopmental Outcomes of the SAFE Early Intervention in Infants at Risk: A Randomised Controlled Trial

Ramazan Yildiz et al. J Paediatr Child Health. 2025 Oct.

Abstract

Background: Early intervention for infants at risk of cerebral palsy (CP) plays a critical role in improving neurodevelopmental outcomes. Recently, approaches emphasising infant active participation and family collaboration have shown greater effectiveness compared to traditional methods.

Aims: This study aimed to evaluate the effects of the SAFE early intervention approach on cognitive, language, and motor development in infants at risk for CP, in comparison to conventional neurodevelopmental treatment (NDT) practices.

Methods: In this randomised controlled trial, 46 infants were assigned to either the SAFE intervention group (n = 23) or the control group receiving NDT-based care (n = 23). The intervention lasted for 3 months, with developmental assessments conducted at 6 and 12 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III).

Results: Significant improvements were observed in motor and language composite scores in the SAFE group between baseline (T1) and the 3-month follow-up (T2), while cognitive scores showed a non-significant increase. Compared to the control group, the SAFE group demonstrated significantly higher scores across all Bayley-III domains at T2. However, the time × group interaction was significant in favour of the SAFE group for motor scores, while cognitive scores favoured the control group. No significant interaction was observed for language scores. Over time, both groups showed developmental progress in various domains, with the SAFE group exhibiting significant motor gains from T1 to T3. The control group showed significant cognitive improvements from T1 and T2 to T3.

Conclusions: The SAFE early intervention model appears to be a feasible and effective approach for infants at risk for CP, especially before a formal diagnosis is made. Its focus on active infant participation, family engagement, and enriched environments supports improved motor development outcomes.

Trial registration: NCT06930482.

Keywords: early intervention; enriched environment; infants at risk; physiotherapy.

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