NCT06361134

Efficacy of Supporting SAFE Early Intervention

Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 1 Month – 3 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infant Development
• Physiotherapy
• Early Intervention

Interventions

Type	Name	Description
BEHAVIORAL	SAFE Early İntervention	As part of the intervention, sensory-based intervention was applied in an enriched environment. In the home setting, physiotherapists collaborated with the family to advance the intervention. The intervention was revised by making monthly home visits to infants with a corrected age of 42 weeks.
BEHAVIORAL	NDT based therapy	Neuromotor evaluations of the babies were performed in a clinical setting. The rehabilitation program to be implemented was given to the family as a booklet. The programs of the children examined in the clinic every month were revised.

Timeline

• Start date: 2021-01-15
• Primary completion: 2022-05-15
• Completion: 2022-11-15
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: Turkey (Türkiye)