Cognitive Developmental Delay
Conditions
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.
Interventions
OTHERNeurocognitive Follow-up
Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Months to 25 Months
Healthy volunteers
Yes
Inclusion criteria
1. Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA. 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.
Exclusion criteria
1\. Infants identified retrospectively as not meeting the inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Head circumference | At enrollment, 18 and 24 months of CA | Child head circumference (cm) |
| 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. |
| 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) |
| 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 |
| 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 |
Countries
Poland, Slovakia
Outcome results
None listed