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OpenTrials
Completed

NCT Number: NCT04442477

Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.

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Key information

Conditions

Cognitive Ability, General

Age range

64 month–68 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuyang Fifth People's Hospital

Anhui, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant who previously consumed study formula through one year of age in MJN Project 6027
  • 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
  • Signed informed consent obtained for child's participation in the study

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Enriched Protein Fractions

Dietary Supplement

Enriched protein fractions

Protein Fraction

Dietary Supplement

Protein fractions

Primary outcomes

  1. Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)

    Time frame: At 5.5 years of age

Secondary outcomes

  1. Dimensional Change Card Sort (DCCS)

    Time frame: At 5.5 years of age

  2. Stroop Task

    Time frame: At 5.5 years of age

  3. Functional Near Infrared Spectroscopy (fNIRS)

    Time frame: At 5.5 years of age

  4. Child Behavior Checklist (CBCL)

    Time frame: At 5.5 years of age

  5. Body weight

    Time frame: At 5.5 years of age

  6. Body height

    Time frame: At 5.5 year of age

  7. Health history outcomes

    Time frame: At 5.5 years of age

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2020
Registry last updated
Dec 16, 2021

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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