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Effect of Feeding Mode on Infant Growth and Cognitive Function

NCT ID: NCT02626143

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Investigational nutrient-rich whey protein formula

Group Type EXPERIMENTAL

Investigational nutrient-rich whey protein formula

Intervention Type OTHER

Cow's milk based formula

Group Type ACTIVE_COMPARATOR

Cow's milk based formula

Intervention Type OTHER

Breast milk

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Investigational nutrient-rich whey protein formula

Intervention Type OTHER

Cow's milk based formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
* Feeding difficulties or formula intolerance
* Receiving complementary feedings
Minimum Eligible Age

0 Days

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Nutricion y Tecnologia de los Alimentos (INTA)

UNKNOWN

Sponsor Role collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol Lynn Berseth, MD

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Locations

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Instituto de Nutricion y Tecnologia de los Alimentos

Santiago, , Chile

Site Status

Countries

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Chile

References

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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.

Reference Type DERIVED
PMID: 32423392 (View on PubMed)

Other Identifiers

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6029

Identifier Type: -

Identifier Source: org_study_id