Long Term Neurodevelopmental Impact of the Type of Feeding During the First Year of Life Neuroimaging and Electrophysiology Follow up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- To determine if intake of bMFGM during the first year improves brain structure at 9 ys.
Study Overview
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.
Detailed Description
To test our hypothesis, this study proposes to investigate our conceptual model's direct and indirect associations using a combination of low-field MRI, electrophysiology, and psychometric assessments of executive functioning and general cognitive development, expecting to re-enroll approx 100 participants. These children will undergo ERPs, low-field MRI and neurocognitive testing to evaluate brain structure, function, and cognitive development.
The Go/No-Go task assesses inhibitory control, one of the most important executive function. Its development has been studied electrophysiologically using event-related potentials (ERPs), in tasks that require active inhibition when there is a previously learned or prepotent response. The main relevant ERP components are the N2 and P300. The N2, an early negative deflection, has been interpreted to reflect attention, the P300, a later positive wave, is thought to reflect resource allocation. The P300 is typically greater in the inhibitory than in the prepotent response components of tasks such as the Go/No-Go task. Behavioral responses such as accuracy and reaction time have also been studied as measures of development (2). Using the collected data, inhibitory control, as one of the earliest executive functions to begin developing, will be studied.
The data acquired with the Low-field MRI quantify and compare brain structure and myelination patterns (derived from MRI) across the feeding groups in specific white matter pathways and brain regions involved in executive function (EF) and throughout the brain generally. MRI comparisons and comparisons will be complemented by comparisons of ERP measures collected during an inhibition task, which assesses functional development and processing speed.In addition to these group-wise comparisons,it will be explored the direct and indirect infant feeding -> brain structure and function -> executive function and cognitive performance associations using a series of ANCOVA and general linear modeling methods.
C. PRIMARY OBJECTIVE AND OUTCOME MEASUREMENTS:
The primary objective of this study is to determine whether additional intake of bMFGM during infancy (0-12 months of age) improves brain structure, function, and cognitive performance (specifically EF) at early school age (8-10 years of age).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy, have been studied at 2 and 6 years old in the laboratory -
Exclusion Criteria
- •To have a diagnosis of a neurological disease.
Outcomes
Primary Outcomes
To determine if intake of bMFGM during the first year improves brain structure at 9 ys.
Time Frame: MRI assessment will be performed at 9 years old in a session of 45 minutes
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)
To determine if intake of bMFGM during the first year improves EF measures by ERPs at 9ys.
Time Frame: ERPs assessment will be performed at 9 years old in a a second session of 90 minutes .
. 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.
To determine if intake of bMFGM during the first year improves EF measures by questionnaire EFECO.
Time Frame: 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 .
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Cecilia Algarin
Adjunct Professor
Corporación de Apoyo de la Investigación Científica en Nutrición