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

Gazi University

Status: Completed

Conditions: Infant, Premature, Diseases

Treatments: Procedure: SAFE early intervention approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04889846

E-77082166-302.08.01-48434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 9 to 10 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

SAFE early intervention group

Experimental group

Description:

A family collaborative treatment program based on sensory strategies, activity-based motor training and environmental enrichment principles was created for the infants in the treatment group. Within the scope of the SAFE treatment approach, appropriate activities were explained to the families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. The homes of the families in the treatment group were visited at least once. During this visit, home environment was evaluated. In order to create an enriched home environment, families were informed about the toys and materials that can be obtained. The family's questions about the program were answered.

Treatment:

Procedure: SAFE early intervention approach

Control group

Experimental group

Description:

Within the scope of this study, the infants in the control group were given an NDT-based family training program in accordance with their corrected months and current functional levels. In this context, appropriate activities were taught to families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. One visit was made to the homes of the families in the control group. The family's questions about the program were answered.

Treatment:

Procedure: SAFE early intervention approach