Follow up of Long Term Neurodevelopmental Impact of the Type of Feeding During the First Year of Life at 10 Years Old

NCT06917625 | Active Not Recruiting

• 1 other identifier: MJCINUT8736
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The Chilean infant Nutrition Trial was a prospective, randomized, double-blind, controlled study conducted in Santiago, Chile, between 2016 and The study aimed to evaluate growth and body composition changes between birth and two years of age in a large sample of children who were randomized to receive either infant formula with or without added MFGM (milk fat globule membrane) through 12 months of age or received human milk as part of the reference group. In a subsample of 160 children, neurodevelopmental were assessed at 6 months and 24 months.

Conditions

Child Development

Keywords

early nutrition; brain development

Outcome Measures

Primary Outcomes (3)

• To determine if intake of bMFGM during the first year improves brain structure at 9 ys.

  Low-Field MRI will be used to assess general brain growth and morphometry (total brain volume, whole-brain white and gray matter volume, and cortical and sub-cortical structure volumes) as well as myelination using myelin-sensitive MRI. For specific analysis will examine brain regions involved in EF, including prefrontal cortex, hippocampus, amygdala, thalamus, motor and somatosensory cortices, and auditory cortex ; and connecting white matter regions, including corpus callosum, cingulum, superior longitudinal fasciculus, and anterior thalamic radiations .The results will be expressed by mean volumetric measures calculate from the MRI data using validated FreeSurfer software and compared across the groups using an ANCOVA, controlling for variables of interest. Mean myelin measures will be calculated for each white matter pathway and to identify significant differences (express by grade of myelination)

  MRI assessment will be performed at 9 years old in a session of 45 minutes

• To determine if intake of bMFGM during the first year improves EF measures by ERPs at 9ys.

  . To assess EF the Go No Go task will be performed with ERPs. The participant will ask to press a button when any letter appears (Go stimulus) except when the letter will be X (No Go stimulus). There will be 2 blocks: Block 1(40 trials) of Go stimulus and Block 2 (200 trials) of randomized Go and No Go stimuli. Neurophysiological responses will be recorded from 128 scalp sites using a recording system with a geodesic sensor net .For the ERP analysis, the major positive and negative peaks following stimulus onset will be identified. Statistical analyses were conducted with SPSS software version 25.0.1. Behavioral measures will be reaction time (ms) and accuracy (%). Electrophysiological results will be the peak amplitude (mµ) and latency (ms) for the waves N2 and P300.

  ERPs assessment will be performed at 9 years old in a a second session of 90 minutes .

• To determine if intake of bMFGM during the first year improves EF measures by questionnaire EFECO.

  The questionnaire EFECO evaluates executive functions throughout conductual observation. The scale has 67 questions which measure seven different executive functions: cognitive flexibility, emotional control, planification capacity, organization, initiative and working memory. The quantification of each item goes from 0 to 3 according with one of these responses: Never, sometime, frequently, and very frequently. The higher score corresponds to a better EF. The questionnaire will be filled by the adult accompanying the participant during the ERP measurement and confirm that lives with the participant.

  EFECO will be answered by the adult that ERPs assessment will be performed at 9 years old in a a second session of 90 minutes .

Study Arms (1)

FM EM

During the first year of life the participants received 1. regular formula milk 2. enriched with Milk Fat Membrane Globule formula

Diagnostic Test: Imaging

Interventions

Imaging DIAGNOSTIC_TEST

The participants will be assessed with a brain MRI and will performed a neurophysiological test to evaluate executive functions

Also known as: Event related potential test

FM EM

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Study population was selected from the neighborhoods close to the installation of research institute. The area corresponds to the southeast of Santiago, Chile

Sponsors & Collaborators

• Corporación de Apoyo de la Investigación Científica en Nutrición: lead

Study Sites (1)

CINUT

Santiago, RM, Chile

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Patricio Peirano, MD

  University of Chile

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: March 11, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and 1 year after the publication
• Access Criteria: By a written request to the authors

Locations

CL (1)