An observational study in Cognitive Developmental Delay, sponsored by Société des Produits Nestlé (SPN). Completed at 3 sites in 2 countries. Open to participants aged 17 Months to 25 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Société des Produits Nestlé (SPN) · Observational
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.
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Neurocognitive Follow-up of children previously having participated in the Alprem RTF study
Other: Neurocognitive Follow-up
Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
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.
Time frame: 24 months of CA
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.
Time frame: 18 months of CA
Weight
Child weight (g)
Time frame: At enrollment, 18 and 24 months of CA
Length/height
Child length/height (cm)
Time frame: At enrollment, 18 and 24 months of CA
Head circumference
Child head circumference (cm)
Time frame: 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
Time frame: 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)
Time frame: At 18 and 24 months of CA
Number of healthcare usage
Retrospective parent-reported recall of the number of healthcare usage and hospitalizations
Time frame: 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
Time frame: At 18 and 24 months of CA
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)