Effect of SAFE Early Intervention Program on Neurodevelopmental Outcomes At 1 Year of Age in Infants at Risk of CP
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Bayley Scales of Development for Infants and Toddlers III (Bayley-III)
Study Overview
Brief Summary
In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Corrected age of 3 months
- •Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)
Exclusion Criteria
- •Having a congenital anomaly
- •Having a genetic syndrome diagnosis (e.g. Down Syndrome)
- •Parents do not speak Turkish
Arms & Interventions
SAFE Early Intervention Group
Intervention: Safe early intervention (Behavioral)
SAFE Early Intervention Group
Intervention: early intervention approach based on neurodevelopmental treatment (Behavioral)
Control Group
Intervention: early intervention approach based on neurodevelopmental treatment (Behavioral)
Control Group
Intervention: Safe early intervention (Behavioral)
Outcomes
Primary Outcomes
Bayley Scales of Development for Infants and Toddlers III (Bayley-III)
Time Frame: 3 months,6 months, 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Ayse Simsek
Principal Investigator
Gazi University