Neurocognitive Follow-Up (FU) Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years

Conditions
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Cognitive Developmental Delay

Intervention / Treatment
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* Other: Neurocognitive Follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 1. Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.

Ages Eligible for Study
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Minimum Age: 17 Months
Maximum Age: 25 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alprem RTF Brain Follow-up<br>Neurocognitive Follow-up of children previously having participated in the Alprem RTF study | Other: Neurocognitive Follow-up<br>* Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |