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This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).
This is a follow-up study of a recently completed multi-center, prospective, single-arm, open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit and continuing until 30 days post-discharge.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprem RTF Brain Follow-up | Neurocognitive Follow-up of children previously having participated in the Alprem RTF study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurocognitive Follow-up | Other | Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bayley-III scores at 24 months | Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 24 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development. | 24 months of CA |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley-III scores at 18 months | Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 18 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development. | 18 months of CA |
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Inclusion Criteria:
Exclusion Criteria:
1. Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.
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Infants who have previously participated in the 17.14.INF Alprem RTF study are eligible to participate, wherein preterm infants of gestational age ≥ 27 weeks and ≤ 32 weeks with body weight <1500g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart had been enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy | Krakow | 30-663 | Poland | |||
| Univerzitna nemocnica Martin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39649400 | Derived | 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. |
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| Weight | Child weight (g) | At enrollment, 18 and 24 months of CA |
| Length/height | Child length/height (cm) | At enrollment, 18 and 24 months of CA |
| Head circumference | Child head circumference (cm) | At enrollment, 18 and 24 months of CA |
| Child temperament scores | Parent-reported child temperament questionnaire validated specifically for children between the ages of 18 and 36 months | At 18 and 24 months of CA |
| Developmental Milestone scores | Parent-reported achievements of specific age-appropriate milestones (yes/no responses to child performing specific milestones or not) | At 18 and 24 months of CA |
| Number of healthcare usage | Retrospective parent-reported recall of the number of healthcare usage and hospitalizations | At 18 and 24 months of CA |
| Feeding patterns | Feeding practice outcomes collected retrospectively at each visit via a parent-reported questionnaire related to breastfeeding duration, prevalence of formula feeding, and age at initiation of complementary feeding | At 18 and 24 months of CA |
| Martin |
| 3659 |
| Slovakia |
| Fakultna nemocnica s poliklinikou Nove Zamky | Nové Zámky | 940 34 | Slovakia |