Infant Nutrition and Brain Development

Nestlé

Status: Completed

Conditions: Healthy; Infant Development

Treatments: Other: Infant Formula: enriched level of myelin-relevant nutrients; Other: Infant formula: standard level of myelin-relevant nutrients

Study type: Interventional

Funder types: Industry

Identifiers

NCT03111927

16.14.NRC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 189 patients

Sex: All

Ages: 2 to 6 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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189 participants in 3 patient groups

Reference Arm: Breastfed

No Intervention group

Description:

Epidemiological reference group of breastfed infants.

Investigational

Experimental group

Description:

Infant Formula: enriched level of myelin-relevant nutrients

Treatment:

Other: Infant Formula: enriched level of myelin-relevant nutrients

Control

Active Comparator group

Description:

Infant formula: standard level of myelin-relevant nutrients

Treatment:

Other: Infant formula: standard level of myelin-relevant nutrients