Neurocognitive Follow-Up (FU) Study (AlpremFU)

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

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).

Study Overview

• Status: Completed
• Conditions: Cognitive Developmental Delay
• Intervention / Treatment: Other: Neurocognitive Follow-up

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 30-663
    • Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy
• Slovakia
  • Martin, Slovakia, 3659
    • Univerzitná nemocnica Martin
  • Nove Zamky, Slovakia, 940 34
    • Fakultna nemocnica s poliklinikou Nove Zamky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alprem RTF Brain Follow-up; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2006INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No