Healthy, Infant Development
Conditions
Keywords
Nutrition, Brain Development, Cognition, Heathy Infants
Brief summary
Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.
Detailed description
This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development. Once all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed. Product codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.
Interventions
OTHERInfant Formula: enriched level of myelin-relevant nutrients
Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks). The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
OTHERInfant formula: standard level of myelin-relevant nutrients
Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks). The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind - Infant Formula arms are blinded; * Reference Arm - unblinded epidemiological reference arm * Allocation: Randomized for formula arms, efficacy study
Intervention model description
Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants. 3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infants
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 6 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Term infants (≥ 37 weeks) * Neuro typical development * No major risk factors for learning, neurologic, or psychiatric disorder * Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks. * Parents/legal guardians willing and able to complete the informed consent process
Exclusion criteria
* Delayed birth (\> 41 weeks gestation) * Birth Weight \< 2000 g or small for gestation age or large for gestational age * Psychopharmacological treatment of mother using prohibited medications during pregnancy * In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists * Abnormalities on fetal ultrasound * Complicated pregnancy * Neonatal intensive care unit admission and/or emergency surgical delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Social Emotional Development | 3, 6, 12, 18, and 24 months of life | Parent report questionnaire. |
| Brain structural connectivity | 3, 6, 12, 18, and 24 months of life | Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \[Physiological marker, MRI\]. |
| Brain functional connectivity | 3, 6, 12, 18, and 24 months of life | Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \[Physiological marker, MRI\]. |
| Brain De novo myelination | 3, 6, 12, 18, and 24 months of life | Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) \[Physiological marker, MRI\]. |
| Infant Cognitive Development | 6, 12, and 24 months of life | Standardized neurodevelopment test. |
| Infant Early Learning Assessment | 18 and 24 months of life | Computer-based cognitive tasks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast milk nutrients profile | week 3, week 6, and 3 months of life | Nutrients (vitamins, minerals, and other nutrients) levels analyses in breast milk nutrients (subsample) \[Physiological parameter\]. |
| Brain structure | 3, 6, 12, 18, and 24 months of life | MRI |
| Blood nutrients profile (optional) | 6, 12, and 24 months of life | Nutrients (vitamins, minerals, and other nutrients) levels |
| Sleep | 3, 6, 12, 18, and 24 months of life | Questionnaire |
| Infant dietary assessment | 6, 9, 12, 18, and 24 months of life | Three days food records are planned at the specified time-frames. |
Countries
United States
Outcome results
None listed