Infant Nutrition and Brain Development



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:9/7/2018
Start Date:March 13, 2017
End Date:July 30, 2021
Contact:Ileana Alexander
Email:Ileana.Alexander@rd.nestle.com
Phone:(973) 593-7461

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The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development

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 will
be compared and a breastfed group will be considered as epidemiological reference.

This nutritional intervention study involves assessments in both the mother and her infant.
The mother will be asked to complete self-report questionnaires and to undergo a brief
cognitive assessment. If the mother is not breastfeeding, a study product will be provided
and will be consumed by the infant daily up to 12 months of life. The study also involves
magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as
evaluations of general cognitive and social-emotional development.

Inclusion Criteria:

- Term infants (≥ 38 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.

Exclusion Criteria:

- Delayed birth (> 41 weeks gestation)

- Birth Weight < 2500 g or small for gestation age or large for gestational age

- Psychopharmacological treatment of mother using prohibited medications during
pregnancy

- Multiple birth

- Abnormalities on fetal ultrasound

- Complicated pregnancy

- APGAR scores less than 8

- Neonatal intensive care unit admission and/or emergency surgical delivery

- Abnormal screening laboratory values and studies considered to be clinically
significant in the opinion of the Investigator
We found this trial at
1
site
111 Brewster St
Pawtucket, Rhode Island 02860
(401) 729-2000
Phone: 401-338-6943
Memorial Hospital of Rhode Island Memorial Hospital of Rhode Island is a 294-bed community teaching...
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mi
from
Pawtucket, RI
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