Efficacy of Supporting SAFE Early Intervention

Gazi University

Status: Completed

Conditions: Physiotherapy; Infant Development; Early Intervention

Treatments: Behavioral: NDT based therapy; Behavioral: SAFE Early İntervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06361134

14574941-302,08,01-

Details and patient eligibility

About

Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.

Enrollment: 26 patients

Sex: All

Ages: 1 to 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),

Having a NICU history of 15 days or more,

Exclusion criteria

congenital malformations, metabolic and genetic disease musculoskeletal system anomaly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

26 participants in 2 patient groups

SAFE Early Intervention Group

Experimental group

Description:

A sensory-based, activity-focused early intervention program was implemented in an enriched environment (SAFE Early intervention). Children in the intervention group received home visits once a month and their families were coached. Families were informed about how to support their children. Home visits were made once a month for 10 weeks.

Treatment:

Behavioral: SAFE Early İntervention

Behavioral: NDT based therapy

Control Group

Experimental group

Description:

Home-based NDT program was applied to the control group. The babies in the group were examined in a clinic environment and the families were given booklets to support their children's development.

Treatment:

Behavioral: SAFE Early İntervention

Behavioral: NDT based therapy