Status:

COMPLETED

Evaluation of The Effectiveness of The SAFE Early Intervention Program

Lead Sponsor:

Gazi University

Conditions:

Preterm

Sensory Disorders

Eligibility:

All Genders

3-12 years

Phase:

NA

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 cognit...

Eligibility Criteria

Inclusion

  • • Corrected age of 3 months
  • Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

Exclusion

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

Key Trial Info

Start Date :

January 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2023

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT06930482

Start Date

January 1 2021

End Date

January 1 2023

Last Update

April 16 2025

Active Locations (1)

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1

Erzurum Technical University

Erzurum, Turkey (Türkiye)