Effect of Feeding Mode on Infant Growth and Cognitive Function
1 other identifier
interventional
582
1 country
1
Brief Summary
This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedNovember 13, 2020
November 1, 2020
3 years
December 3, 2015
November 10, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Body weight
24 months
Auditory Event-related Potential
24 months
Body length
24 months
Head circumference
24 months
Secondary Outcomes (12)
Dietary Intake
24 months
Medically confirmed adverse events
24 months
Body Composition: Air Displacement Plethysmography
6 months
Body Composition: Deuterium Dilution
12 and 24 months
Blood sample: Micronutrient status
24 months
- +7 more secondary outcomes
Study Arms (3)
Investigational nutrient-rich whey protein formula
EXPERIMENTALCow's milk based formula
ACTIVE COMPARATORBreast milk
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Singleton, 0-120 days of age at study entry
- Term infant with birth weight of 2500 to 4500 grams
- Exclusively feed infant formula or exclusively feeding breast milk
- Signed informed consent
You may not qualify if:
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
- Feeding difficulties or formula intolerance
- Receiving complementary feedings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Nutricion y Tecnologia de los Alimentos
Santiago, Chile
Related Publications (1)
Toro-Campos R, Algarin C, Peirano P, Pena M, Murguia-Peniche T, Wu SS, Uauy R. Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT). BMC Pediatr. 2020 May 18;20(1):225. doi: 10.1186/s12887-020-02087-9.
PMID: 32423392DERIVED
Study Officials
- STUDY DIRECTOR
Carol Lynn Berseth, MD
Mead Johnson Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2015
First Posted
December 10, 2015
Study Start
February 1, 2016
Primary Completion
February 1, 2019
Study Completion
March 1, 2019
Last Updated
November 13, 2020
Record last verified: 2020-11