Evaluation of The Effectiveness of The SAFE Early Intervention Program

Not Applicable

Completed

• Conditions: Preterm; Sensory Disorders; Cerebral Palsy

• Registration Number: NCT06930482
• Lead Sponsor: Gazi University

Brief Summary

In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-09-01
• Study Completion: 2023-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Corrected age of 3 months

• Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

Exclusion Criteria

• Having a congenital anomaly

• Having a genetic syndrome diagnosis (e.g. Down Syndrome)
• Parents do not speak Turkish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bayley Scales of Development for Infants and Toddlers III (Bayley-III)	3 months,6 months, 12 months

Trial Locations

Locations (1)

Erzurum Technical University; 🇹🇷 Erzurum, Turkey