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The Effect of Feeding Infant Formula With Enriched Protein Fractions

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ClinicalTrials.gov Identifier: NCT02274883
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Shanghai Children's Medical Center
Information provided by (Responsible Party):
Mead Johnson Nutrition

Tracking Information
First Submitted Date  ICMJE October 16, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date September 1, 2017
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
Infant cognitive development [ Time Frame: At 12 months of age ]
Cognitive Scale of Bayley-III is used as the assessment tool.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
  • Infant cognitive development [ Time Frame: At 18 months of age ]
    Cognitive Scale of Bayley-III is used as the assessment tool.
  • 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.
  • 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.
  • Infant temperament [ Time Frame: At 12 and 18 months of age ]
    Carey Scale is used as assessment tool.
  • Infant attention capabilities [ Time Frame: At 12 and 18 months of age ]
    Single Object Attention and Free Play Tasks is used as assessment tool.
  • 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.
  • 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.
  • 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.
  • 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.
  • Medically-confirmed Adverse Events [ Time Frame: Up to 19 months of age ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Feeding Infant Formula With Enriched Protein Fractions
Official Title  ICMJE The Effect of Feeding Infant Formula With Enriched Protein Fractions
Brief Summary This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Detailed Description To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Cognitive Ability, General
Intervention  ICMJE
  • Dietary Supplement: Enriched Protein Fractions
    Enriched protein fractions
  • Dietary Supplement: Protein Fractions
    Protein fractions
Study Arms  ICMJE
  • Experimental: Enriched Protein Fractions
    This group is given Infant formula with enriched protein fractions.
    Intervention: Dietary Supplement: Enriched Protein Fractions
  • Active Comparator: Protein Fractions
    This group is given Infant formula with protein fractions.
    Intervention: Dietary Supplement: Protein Fractions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2016)
451
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2014)
450
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02274883
Other Study ID Numbers  ICMJE 6027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mead Johnson Nutrition
Study Sponsor  ICMJE Mead Johnson Nutrition
Collaborators  ICMJE Shanghai Children's Medical Center
Investigators  ICMJE
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
PRS Account Mead Johnson Nutrition
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP