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
60 participants
INTERVENTIONAL
2018-06-01
2020-04-30
Brief Summary
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Detailed Description
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There is no developmental support program as standard care in Turkey for premature babies. So that neither intervention nor the control group doesn't take any other support. There will be an average of six intervention sessions during the 6 months intervention period. The assessments will take before intervention (T0), after 3 months after T0 (T1) and after six months after T0 (T2), corrected age one (T3), corrected age two (T4).
Intervention: EXPLORatory motor behavior based Early Intervention Program (Explorer Baby) is a developmental support program for babies and their families. Parents visit the early intervention center with their babies in a variable frequency. The first step of the program is to build up interaction between therapists and parents; worries of parents for the development of their babies, knowledge about child development, knowledge about play behaviors, how babies learn new skills, age-specific requirements of babies, build up interaction with babies and family members, describing blocks for development.
The second step is setting the play in the natural environment working with the family; how do families describe the play? If families want to support the ability of their babies kicking, reaching, rolling, communicate, or social interaction how should they organize the playground? Showing families some examples of enrichment of playground for specific aims.
The third step is observing babies' reactions; how do families motivate their babies for play? How do families encourage their babies for self-starting explorative behaviors? How do parents support making the voice of the baby more if the play context is meaningful for creating a voice? The program doesn't give specific play homework to improve specific skills. The program tries to enrich parents' knowledge about the effect on the behavior of babies in meaningful situations.
The control Group: The control group will take neurodevelopmental therapy. Neurodevelopmental therapy is commonly accepted as traditional therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The Explorer Early Intervention Program
The Explorer Early Intervention Program is used in this group.
The Explorer Baby Early Intervention Program
Centered based intervention, once or twice a month, 6 months follow up
Neurodevelopmental Therapy
Neurodevelopmental therapy is used in these group by two experienced and certificated physiotherapist
Neurodevelopmental Therapy
Centered based intervention, once or twice a month, 6 months follow up
Interventions
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The Explorer Baby Early Intervention Program
Centered based intervention, once or twice a month, 6 months follow up
Neurodevelopmental Therapy
Centered based intervention, once or twice a month, 6 months follow up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Zubeyir Sari
Associate Professor
Principal Investigators
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Zübeyir Sarı, PhD
Role: STUDY_DIRECTOR
Marmara University
Locations
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Marmara University
Istanbul, , Turkey (Türkiye)
Countries
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References
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Babik I, Galloway JC, Lobo MA. Infants Born Preterm Demonstrate Impaired Exploration of Their Bodies and Surfaces Throughout the First 2 Years of Life. Phys Ther. 2017 Sep 1;97(9):915-925. doi: 10.1093/ptj/pzx064.
de Campos AC, Savelsbergh GJ, Rocha NA. What do we know about the atypical development of exploratory actions during infancy? Res Dev Disabil. 2012 Nov-Dec;33(6):2228-35. doi: 10.1016/j.ridd.2012.06.016. Epub 2012 Jul 21.
Altunalan T, Sari Z, Dogan TD, Hacifazlioglu NE, Akman I, Altintas T, Uzer S, Akcakaya NH. Early developmental support for preterm infants based on exploratory behaviors: A parallel randomized controlled study. Brain Behav. 2023 Nov;13(11):e3266. doi: 10.1002/brb3.3266. Epub 2023 Oct 5.
Other Identifiers
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09.2017.729
Identifier Type: -
Identifier Source: org_study_id
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