Neurocognitive Follow-Up (FU) Study

N/ACompletedNCT04962035

Société des Produits Nestlé (SPN)21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cognitive Developmental Delay

Interventions

Neurocognitive Follow-upOTHER

Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.

Eligibility

Sex: ALLMin age: 17 MonthsMax age: 25 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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 exclusion criteria for the original study.

Locations (3)

Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy

Krakow, Poland

Univerzitna nemocnica Martin

Martin, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, Slovakia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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