Status:

COMPLETED

The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey

Lead Sponsor:

Gazi University

Conditions:

Infant, Premature, Diseases

Eligibility:

All Genders

9-10 years

Phase:

NA

Brief Summary

In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environme...

Detailed Description

Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the devel...

Eligibility Criteria

Inclusion

  • Being born before 37 weeks
  • A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
  • Adjusted age to be between 9-10 months
  • Family's willingness to participate in the study

Exclusion

  • Having a congenital anomaly or systemic disease
  • Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).

Key Trial Info

Start Date :

October 15 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 2 2021

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT04889846

Start Date

October 15 2019

End Date

November 2 2021

Last Update

November 3 2021

Active Locations (1)

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1

Gazi University Faculty of Health Sciences Department of Pyhsiotherapy and Rehabilitation

Ankara, Turkey (Türkiye), 06560