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
21 participants
OBSERVATIONAL
2021-03-26
2021-12-22
Brief Summary
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Detailed Description
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Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). The timing of the cognitive assessments aligns with routine check-up visits and reflect the period at which developmental delays may first become evident.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Alprem RTF Brain Follow-up
Neurocognitive Follow-up of children previously having participated in the Alprem RTF study
Neurocognitive Follow-up
Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
Interventions
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Neurocognitive Follow-up
Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
Eligibility Criteria
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Inclusion Criteria
2. Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
17 Months
25 Months
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy
Krakow, , Poland
Univerzitna nemocnica Martin
Martin, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, , Slovakia
Countries
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References
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Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.
Other Identifiers
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2006INF
Identifier Type: -
Identifier Source: org_study_id
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