Infant Nutrition and Brain Development

Not Applicable

Completed

• Conditions: Healthy; Infant Development

• Registration Number: NCT03111927
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2017-02-28
• Study Start: 2017-03-13
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Primary Completion: 2021-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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 Social Emotional Development	3, 6, 12, 18, and 24 months of life	Parent report questionnaire.

Secondary Outcome Measures

Name	Time	Method
Infant dietary assessment	6, 9, 12, 18, and 24 months of life	Three days food records are planned at the specified time-frames.
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) \[Physiological parameter\].
Blood nutrients profile (optional)	6, 12, and 24 months of life	Nutrients (vitamins, minerals, and other nutrients) levels
Brain structure	3, 6, 12, 18, and 24 months of life	MRI
Sleep	3, 6, 12, 18, and 24 months of life	Questionnaire

Trial Locations

Locations (2)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States