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OpenTrials
Completed

NCT Number: NCT02626143

Effect of Feeding Mode on Infant Growth and Cognitive Function

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.

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Key information

Conditions

Infant Nutrition

Age range

0 day–120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Nutricion y Tecnologia de los Alimentos

Santiago, Chile

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Investigational nutrient-rich whey protein formula

Other

Cow's milk based formula

Other

Primary outcomes

  1. Body weight

    Time frame: 24 months

  2. Auditory Event-related Potential

    Time frame: 24 months

  3. Body length

    Time frame: 24 months

  4. Head circumference

    Time frame: 24 months

Secondary outcomes

  1. Dietary Intake

    Time frame: 24 months

  2. Medically confirmed adverse events

    Time frame: 24 months

  3. Body Composition: Air Displacement Plethysmography

    Time frame: 6 months

  4. Body Composition: Deuterium Dilution

    Time frame: 12 and 24 months

  5. Blood sample: Micronutrient status

    Time frame: 24 months

  6. Blood sample: Metabolic markers

    Time frame: 24 months

  7. Bayley Scales of Infant and Toddler Development

    Time frame: 12 months

  8. Sleep measures (Amount of time awake & asleep in a 7-day period)

    Time frame: 24 months

  9. Language development: Native3 Phoneme Repertory

    Time frame: 12 months

  10. Language development: Word Discovery

    Time frame: 10 months

  11. Language development: Rule Inference

    Time frame: 10 months

  12. Language development: MacArthur Communicative Development Inventory

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Instituto de Nutricion y Tecnologia de los Alimentos (INTA)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2015
Registry last updated
Nov 13, 2020

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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