The Effect of Feeding Infant Formula With Enriched Protein Fractions

August 31, 2017 updated by: Mead Johnson Nutrition
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Study Type

Interventional

Enrollment (Actual)

451

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

  • China
    • Anhui
      • Fuyang, Anhui, China
        • Fuyang Fifth People's Hospital
      • Fuyang, Anhui, China
        • Fuyang Maternal and Child Health Institute
      • Fuyang, Anhui, China
        • Yinquan Maternal and Child Health Institute

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 week to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10-14 days of age
  • Exclusively formula-fed
  • Singleton birth
  • Gestational age of 37-42 weeks
  • Birth weight of 2500g to 4000g
  • Signed Informed Consent Form

Exclusion Criteria:

  • History of underlying metabolic or chronic disease
  • Congenital malformation
  • Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
  • Evidence of feeding difficulties or intolerance
  • Immunocompromised
  • Head/brain disease/injury

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enriched Protein Fractions
This group is given Infant formula with enriched protein fractions.
Dietary supplement: Enriched Protein Fractions
Enriched protein fractions
Active Comparator: Protein Fractions
This group is given Infant formula with protein fractions.
Dietary supplement: Protein Fractions
Protein fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant cognitive development
Time Frame: At 12 months of age
Cognitive Scale of Bayley-III is used as the assessment tool.
At 12 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant cognitive development
Time Frame: At 18 months of age
Cognitive Scale of Bayley-III is used as the assessment tool.
At 18 months of age
Infant language and motor skills
Time Frame: At 4, 6, 9, 12 and 18 months of age
Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool.
At 4, 6, 9, 12 and 18 months of age
Infant acquisition of social and emotional milestones and adaptive development
Time Frame: At 4, 6, 9, 12 and 18 months of age
Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool.
At 4, 6, 9, 12 and 18 months of age
Infant temperament
Time Frame: At 12 and 18 months of age
Carey Scale is used as assessment tool.
At 12 and 18 months of age
Infant attention capabilities
Time Frame: At 12 and 18 months of age
Single Object Attention and Free Play Tasks is used as assessment tool.
At 12 and 18 months of age
Physical development
Time Frame: At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age
Body weight, length and head circumference are measured.
At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age
Stool characteristics
Time Frame: At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age
According to the recall of parents during the last 24 hours.
At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Formula intake
Time Frame: At 30, 42, 60, 90, 120, 180, 275 and 365 days of age
According to the recall of parents during the last 24 hours.
At 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Fecal microbiome and metabolome profile
Time Frame: Average of 14 days of age and 120 days of age
Fecal microbiome analysis is done at average of 14 days and 120 days of age. While metabolome profile analysis is done at only average of 120 days of age.
Average of 14 days of age and 120 days of age
Medically-confirmed Adverse Events
Time Frame: Up to 19 months of age
Up to 19 months of age

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Collaborators

Shanghai Children's Medical Center

Investigators

  • Study Chair: John Colombo, Doctor, University of Kansas
  • Study Chair: Fei Li, Doctor, Shanghai Children's Medical Center
  • Study Director: Bryan Liu, Doctor, Mead Johnson Nutrition

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)

November 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 6027

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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