NCT04962035

Neurocognitive Follow-Up (FU) Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 17 Months – 25 Months
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Developmental Delay

Interventions

Type	Name	Description
OTHER	Neurocognitive Follow-up	Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.

Timeline

• Start date: 2021-03-26
• Primary completion: 2021-11-30
• Completion: 2021-12-22
• First posted: 2021-07-14
• Last updated: 2023-03-24

Locations

3 sites across 2 countries: Poland, Slovakia