NCT06361134CompletedNot Applicable
Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Test of Infant Motor Profile
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 3 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Test of Infant Motor Profile
Time Frame: 10 weeks
High numerical scores indicate that infants notice and respond to stimuli less than their peers, meaning the infant is hypersensitive, while low numerical scores indicate that infants notice and respond to stimuli more than their peers, or are hypersensitive.
Secondary Outcomes
- Infant/Toddler Sensory Profile 2(10 weeks)
- Bayley Scales of Infant and Toddler Development, Third Edition,(10 weeks)
- Infant/Toddler HOME Inventory(10 weeks)
Investigators
Ayse Simsek
Gazi University
Gazi University
Study Sites (2)
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