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Completed

NCT Number: NCT02274883

The Effect of Feeding Infant Formula With Enriched Protein Fractions

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

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Key information

Conditions

Cognitive Ability, General

Age range

10 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuyang Fifth People's Hospital, Fuyang, Anhui, China

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enriched Protein Fractions

Dietary Supplement

Enriched protein fractions

Protein Fractions

Dietary Supplement

Protein fractions

Primary outcomes

  1. Infant cognitive development

    Time frame: At 12 months of age

    Cognitive Scale of Bayley-III is used as the assessment tool.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Shanghai Children's Medical Center

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 24, 2014
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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