Infant Nutrition and Brain Development

NCT ID: NCT03111927

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2022-02-28

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.

Conditions

Healthy; Infant Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Reference Arm: Breastfed

Epidemiological reference group of breastfed infants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Investigational

Infant Formula: enriched level of myelin-relevant nutrients

Group Type: EXPERIMENTAL

Infant Formula: enriched level of myelin-relevant nutrients

Intervention Type: OTHER

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.

Control

Infant formula: standard level of myelin-relevant nutrients

Group Type: ACTIVE_COMPARATOR

Infant formula: standard level of myelin-relevant nutrients

Intervention Type: OTHER

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.

Interventions

Infant 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.

Intervention Type: OTHER

Infant 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.

Intervention Type: OTHER

Other Intervention Names

Infant Formula; Infant Formula

Eligibility Criteria

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

• Minimum Eligible Age: 2 Weeks
• Maximum Eligible Age: 6 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Deoni, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Viren D'Sa, MD

Role: STUDY_DIRECTOR

Rhode Island Hospital

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

Schneider N, Bruchhage MMK, O'Neill BV, Hartweg M, Tanguy J, Steiner P, Mutungi G, O'Regan J, Mcsweeney S, D'Sa V, Deoni SCL. A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial. Front Nutr. 2022 Feb 10;9:823893. doi: 10.3389/fnut.2022.823893. eCollection 2022.

Reference Type: DERIVED

PMID: 35242798 (View on PubMed)

Other Identifiers

16.14.NRC

Identifier Type: -

Identifier Source: org_study_id