Viewing Study NCT04889846



Ignite Creation Date: 2024-05-06 @ 4:09 PM
Last Modification Date: 2024-10-26 @ 2:04 PM
Study NCT ID: NCT04889846
Status: COMPLETED
Last Update Posted: 2021-11-03
First Post: 2021-05-09

Brief Title: The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey
Sponsor: Gazi University
Organization: Gazi University

Study Overview

Official Title: Investigation of the Effectiveness of Family Collaborative Early Intervention Approach Based on Sensory Strategies Activity Based Motor Training and Environmental Enrichment in Premature Infants SAFE National Early Intervention Approach
Status: COMPLETED
Status Verified Date: 2021-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SAFE
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 environmental enrichment and to examine the effects of this approach on sensory motor cognitive and language development in premature infants
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 development of risky premature infants For these reasons it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country

Within the scope of this study a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature Sensory strategies activity-based motor training family collaboration and environmental enrichment constitute the basic principles of this early intervention program The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach S Sensory Strategies A Activity Based Motor Training F Family Collaboration E Environmental Enrichment

In this study it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Also we aimed to examine the effects of this approach on sensory motor cognitive and language development in preterm infants with corrected ages of 9-10 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None