Efficacy of Supporting SAFE Early Intervention

G

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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