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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

Brief Summary:
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Condition or disease Intervention/treatment Phase
Cognitive Ability, General Dietary Supplement: Enriched Protein Fractions Dietary Supplement: Protein Fractions Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Feeding Infant Formula With Enriched Protein Fractions
Actual Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Infant cognitive development [ Time Frame: At 12 months of age ]
    Cognitive Scale of Bayley-III is used as the assessment tool.


Secondary Outcome Measures :
  1. Infant cognitive development [ Time Frame: At 18 months of age ]
    Cognitive Scale of Bayley-III is used as the assessment tool.

  2. 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.

  3. 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.

  4. Infant temperament [ Time Frame: At 12 and 18 months of age ]
    Carey Scale is used as assessment tool.

  5. Infant attention capabilities [ Time Frame: At 12 and 18 months of age ]
    Single Object Attention and Free Play Tasks is used as assessment tool.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Medically-confirmed Adverse Events [ Time Frame: Up to 19 months of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274883


Locations
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China, Anhui
Fuyang Fifth People's Hospital
Fuyang, Anhui, China
Fuyang Maternal and Child Health Institute
Fuyang, Anhui, China
Yinquan Maternal and Child Health Institute
Fuyang, Anhui, China
Sponsors and Collaborators
Mead Johnson Nutrition
Shanghai Children's Medical Center
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02274883    
Other Study ID Numbers: 6027
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017