Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2021-01-15
2022-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
SAFE Early İntervention
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.
NDT based therapy
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.
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.
SAFE Early İntervention
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.
NDT based therapy
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.
Interventions
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SAFE Early İntervention
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.
NDT based therapy
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
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Inclusion Criteria
Having a NICU history of 15 days or more,
Exclusion Criteria
1 Month
3 Months
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Ayse Simsek
Gazi University
Locations
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Erzurum Technical University
Erzurum, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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14574941-302,08,01-
Identifier Type: -
Identifier Source: org_study_id
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