Neurocognitive Follow-Up (FU) Study

NCT04962035 | Completed

• 1 other identifier: 2006INF
• Study Type: observational
• Target: 21
• Locations: 2 countries
• Sites: 3

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).

Conditions

Cognitive Developmental Delay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Bayley-III scores at 18 months

  18 months of CA

• Weight

  At enrollment, 18 and 24 months of CA

• Length/height

  At enrollment, 18 and 24 months of CA

• Head circumference

  At enrollment, 18 and 24 months of CA

• Child temperament scores

  At 18 and 24 months of CA

Study Arms (1)

Alprem RTF Brain Follow-up

Neurocognitive Follow-up of children previously having participated in the Alprem RTF study

Other: Neurocognitive Follow-up

Interventions

Neurocognitive Follow-up OTHER

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

Alprem RTF Brain Follow-up

Eligibility Criteria

• Age: 17 Months - 25 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (3)

Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy

Krakow, 30-663, Poland

Location

Univerzitna nemocnica Martin

Martin, 3659, Slovakia

Location

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, 940 34, Slovakia

Location

Related Publications (1)

• Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.

  PMID: 39649400 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: July 14, 2021
• Study Start: March 26, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 22, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); PL (1)