Clinical Trials Directory

Trials / Completed

CompletedNCT04889846

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

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
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Gazi University · Academic / Other
Sex
All
Age
9 Months – 10 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESAFE early intervention approachSAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment.

Timeline

Start date
2019-10-15
Primary completion
2021-10-17
Completion
2021-11-02
First posted
2021-05-17
Last updated
2021-11-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04889846. Inclusion in this directory is not an endorsement.