Neurocognitive Follow-Up (FU) Study
- Conditions
- Cognitive Developmental Delay
- Interventions
- Other: Neurocognitive Follow-up
- Registration Number
- NCT04962035
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.
- 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.
- Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alprem RTF Brain Follow-up Neurocognitive Follow-up Neurocognitive Follow-up of children previously having participated in the Alprem RTF study
- Primary Outcome Measures
Name Time Method Bayley-III scores at 24 months 24 months of CA 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.
- Secondary Outcome Measures
Name Time Method Bayley-III scores at 18 months 18 months of CA 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.
Child temperament scores At 18 and 24 months of CA Parent-reported child temperament questionnaire validated specifically for children between the ages of 18 and 36 months
Number of healthcare usage At 18 and 24 months of CA Retrospective parent-reported recall of the number of healthcare usage and hospitalizations
Feeding patterns At 18 and 24 months of CA 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
Head circumference At enrollment, 18 and 24 months of CA Child head circumference (cm)
Developmental Milestone scores At 18 and 24 months of CA Parent-reported achievements of specific age-appropriate milestones (yes/no responses to child performing specific milestones or not)
Weight At enrollment, 18 and 24 months of CA Child weight (g)
Length/height At enrollment, 18 and 24 months of CA Child length/height (cm)
Trial Locations
- Locations (3)
Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy
🇵🇱Krakow, Poland
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
🇸🇰Nove Zamky, Slovakia