Efficacy of Supporting SAFE Early Intervention
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 29, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedApril 11, 2024
March 1, 2022
1.3 years
March 29, 2024
April 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Test of Infant Motor Profile
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.
10 weeks
Secondary Outcomes (3)
Bayley Scales of Infant and Toddler Development, Third Edition,
10 weeks
Infant/Toddler Sensory Profile 2
10 weeks
Infant/Toddler HOME Inventory
10 weeks
Study Arms (2)
SAFE Early Intervention Group
EXPERIMENTALA 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.
Control Group
EXPERIMENTALHome-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),
- Having a NICU history of 15 days or more,
You may not qualify if:
- congenital malformations, metabolic and genetic disease musculoskeletal system anomaly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Erzurum Technical University
Erzurum, Turkey (Türkiye)
Related Publications (1)
Yildiz A, Yildiz R, Apaydin U, Efkere PA, Gucuyener K, Hirfanoglu IM, Elbasan B. Effects of SAFE Early Intervention Approach in the First Months of Life in Infants at Risk: A Randomized Controlled Study. Child Care Health Dev. 2025 Jul;51(4):e70107. doi: 10.1111/cch.70107.
PMID: 40435392DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gazi University
Study Record Dates
First Submitted
March 29, 2024
First Posted
April 11, 2024
Study Start
January 15, 2021
Primary Completion
May 15, 2022
Study Completion
November 15, 2022
Last Updated
April 11, 2024
Record last verified: 2022-03