Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 26
- Locations
- 1
- 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
Arms & Interventions
SAFE Early Intervention Group
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.
Intervention: SAFE Early İntervention (Behavioral)
SAFE Early Intervention Group
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.
Intervention: NDT based therapy (Behavioral)
Control Group
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.
Intervention: SAFE Early İntervention (Behavioral)
Control Group
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.
Intervention: NDT based therapy (Behavioral)
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