Effect of Feeding Mode on Infant Growth and Cognitive Function

November 10, 2020 updated by: Mead Johnson Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

582

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Instituto de Nutricion y Tecnologia de los Alimentos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Investigational nutrient-rich whey protein formula
Other: Investigational nutrient-rich whey protein formula
ACTIVE_COMPARATOR: Cow's milk based formula
Other: Cow's milk based formula
NO_INTERVENTION: Breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 24 months
24 months
Auditory Event-related Potential
Time Frame: 24 months
24 months
Body length
Time Frame: 24 months
24 months
Head circumference
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dietary Intake
Time Frame: 24 months
24 months
Medically confirmed adverse events
Time Frame: 24 months
24 months
Body Composition: Air Displacement Plethysmography
Time Frame: 6 months
6 months
Body Composition: Deuterium Dilution
Time Frame: 12 and 24 months
12 and 24 months
Blood sample: Micronutrient status
Time Frame: 24 months
24 months
Blood sample: Metabolic markers
Time Frame: 24 months
24 months
Bayley Scales of Infant and Toddler Development
Time Frame: 12 months
12 months
Sleep measures (Amount of time awake & asleep in a 7-day period)
Time Frame: 24 months
24 months
Language development: Native3 Phoneme Repertory
Time Frame: 12 months
12 months
Language development: Word Discovery
Time Frame: 10 months
10 months
Language development: Rule Inference
Time Frame: 10 months
10 months
Language development: MacArthur Communicative Development Inventory
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Collaborators

Instituto de Nutricion y Tecnologia de los Alimentos (INTA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (ESTIMATE)

December 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 6029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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